This project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement 733203 and the German Research Foundation (DFG).

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The Clinical Trial Centre Leipzig (ZKS Leipzig) is a non-profit organisation, established in 1999 as part of the Medical Faculty of the University Leipzig (UNI-Leipzig). It offers advice and support to investigators in the planning, conduct, analysis and evaluation of clinical trials and patientrelated research projects. The services offered by the ZKS Leipzig are primarily, but not exclusively, designed to support investigator-initiated trials.

 

The Innovation Center Computer Assisted Surgery (ICCAS) will provide support with one side project for patient-based individual modeling of Paraspinal Collateral Network Perfusion after Segmental Artery Occlusion (Pim-PaP) to integrate clinically acquired angioCT data (and 4D flow MRI available from selected sites).

 

The Saxonian Incubator for Clinical Translation (SIKT) is a young research institute funded by the State of Saxony aiming to employ over 100 of ‘the best and the brightest’ among young German scientist by 2018 to drive translational cardiovascular medicine in Saxony.

The department of Cardiovascular Surgery at the Inselspital / University hospital of Bern (herzundgefaesse.insel.ch) is the largest cardiovascular service in Switzerland. It has a long established record of excellence in cardiovascular surgery with a special interest in aortic diseases. Approximately 400 aortic interventions are performed per year covering all possible pathologies, including open repair of all thoracoabdominal aortic pathologies. It is the largest clinic of its kind in Switzerland and has a long-standing experience conducting high-quality clinical research.

Alma Mater Studiorum-University of Bologna (UNI-BO), founded in 1008 is the oldest university in the Western world. The campus integrates genetic and biomolecular expertise that complete the cardiovascular department competence. It also supports investigators in the analysis and evaluation of clinical research projects.

The Freiburg/ Bad Krozingen Heart Center is one of Germany's largest cardiovascular institutions.  Their Aortic Surgery Program has been expanding over the last years and now has a quantity of more than 300 patients/ year. They cover a broad spectrum of endovascular and open aortic surgery, including thoracoabdominal aortic pathologies.

The LMU is the leading teaching and research university in Germany, ranking 1st in Germany in the latest Times Higher Education World University Ranking. With the neighboring Max-Planck, Helmholtz, and Technical University institutions, it can be regarded as a major European science hub. 

The LMU’s Aortic Programm (“Aortic Alliance”) represents an interdisciplinary team, including the departments of cardiac surgery, vascular surgery, anaesthesiology and cardiology. With more than 350 aortic cases per year, the LMU represents one of the leading aortic centres in Germany. The large case-load in combination with the LMU’s research facilities offers optimal conditions for clinical and experimental research in aortic surgery.

In 2005, both departments of vascular surgery from the Maastricht University Medical Center in Maastricht, the Netherlands and the University Hospital Aachen, Germany have merged in to a cross border vascular center, under a single leadership (Prof. Dr. Michael Jacobs). One of the main activities is the treatment of complex aortic pathologies, especially thoraco-abdominal aortic aneurysm (TAAA) repair. In both centers the same protocols exist for endovascular and open repair of TAAA. On an annual base, some 120 TAAA procedures are performed. Since more than 20 years, prevention of spinal cord ischemia is one of the main themes for basic and clinical research. The vascular centre has developed the technique of motor evoked potentials in patients undergoing TAAA repair and have established low incidence of paraplegia. They have created an international cross border telemonitoring network with university hospitals in Germany and Switzerland. Patients operated in these centers are monitored in Maastricht via intranet connections. In addition, the staff are involved in training other centres across Europe in order to create the infrastructure and experience required to treat these complex patients.

Skåne University Hospital (Swedish: Skånes universitetssjukhus, SUS) was founded in 2010 through the merger of the two university hospitals in Lund and Malmö. Skåne University Hospital is strategically located with the Faculty of Medicine at Lund University. They have research environments at the point of care for about 50 research groups. Their activities span a broad range of fields – from molecular medicine to public health. Some of the research is conducted as part of the Lund University Diabetes Centre (LUDC), one of the world’s foremost centres for diabetes research.

The Medical University of Warsaw is one of the oldest medical schools in Poland. For over 200 years it has provided education and training in medicine and pharmacy at undergraduate and postgraduate levels. The university's programs meet the highest international standards of university-level education and are based on the principles of good clinical and pharmaceutical practice. The Medical University of Warsaw provides specialist referral tertiary and general services and undergraduate and postgraduate teaching in its five affiliated teaching hospitals, which are also involved in scientific and clinical research.

The Department of General, Vascular and Transplant Surgery is the biggest, and second oldest center in Poland for endovascular treatment of aortic diseases. They have treated over 2200 patients endovascularly during 18 years’ experience, including almost 300 thoracoabdominal or paravisceral aneurysms.

San Raffaele Scientific Institute, founded in 1971, is a university and research hospital of international standing, highly specialized in several important diseases, including specifically the cardio-thoracic and vascular area. Together with its related Centers, as San Raffaele “Turro” Hospital, polyclinics Cardinal Schuster and San Donato Milanese, the Institute has a total of 1,318 beds, annually carrying out a total of about 35,000 surgical operations, 44,628 admissions, 950,531 outpatient and over 66,600 emergency department procedures.

The Vascular Surgery Department of San Raffaele Scientific Institute, home of the Vascular Surgery Residency Program of “Vita-Salute University”, both directed by Prof. Roberto Chiesa, founded in 1993, has become famous in the Italian and international cardio-vascular community for the publication of several scientific papers on the most prestigious national and international journals of vascular surgery, with a particular focus on thoracic and thoracoabdominal aortic surgery (open and endovascular). The Division performs over 2,100 vascular interventions every year, especially on the thoracic and thoracoabdominal aorta, for which disease the Department is recognized as a High Volume and Tertiary Referral Center in Italy. Prof. Roberto Chiesa and Prof. Germano Melissano organize every two years one of the worlds largest international meetings focused on thoraco-abdominal aortic disease, the “Aortic Surgery: How To Do It” symposium, with more than 1,000 delegates coming from every part of the world.

The University Hospital of Bordeaux is concerned with delivering treatment, promoting prevention, delivering teaching and conducting research. It is composed of three hospital sites in Bordeaux and is working in close collaboration with the University of Bordeaux for education but also research through research units (CNRS and INSERM). The hospital takes an active part in research with more than 240 FTE staff working on clinical research and involvement in several research projects, including FP funded ones. The University Hospital of Bordeaux (CHU de Bordeaux) is one of the largest and most important universities in France with a population of more than 5 million people. The unit of vascular surgery is one of the largest units in France and well recognised for the endovascular and surgical arterial practises. Each year the unit is placed in the top 3 for the most important structures for the arterial treatment in France. The CHU structure involves two separated and complementary structures: vascular unit for the endovascular practice and cardiovascular unit for the open surgical practice.

Örebro University Hospital is a medical center evolving into the hospital of tomorrow. They provide a wide range of accessible basic and highly specialized medical services in a safe and reliable setting. They are proud to serve patients with professionalism, commitment, and personalized care.

Thier highly specialized areas are vascular surgery, which is dominated by endovascular treatments, and obesity surgery. They are currently concentrating on the development of endovascular and combined vascular surgery (hybrid) procedures. Their research focus is on highly specialized areas; epidemiological breast cancer studies, the development of treatments for rectal cancer, and metabolism and inflammation in connection with surgical disease and surgical procedures.The department is well connected via a professorship at Örebro University.

The University Heart Center Hamburg, founded in 2005, provides an integrated approach of patient oriented care and high tech medicine for all patients with cardiovascular disease. The centre comprises of Cardiology, Cardiac Surgery and Vascular Medicine and due to the increasing relevance and new treatment modalities of aortic pathologies the dedicated German Aortic Center Hamburg (DAZH) was founded in 2011. As a multidisciplinary center the GACH provides care for complex aortic disease combining world leading expertise in Cardiology, Cardiac Surgery, Genetics, Anaesthesia and Vascular Medicine. With a steady increase in treatment numbers the DAZH has today become the largest aortic center in Germany with more than 600 open and endovascular operations of the aorta in all segments. Open- and endovascular treatment of thoraco-abdominal aortic aneurysms and dissections with its demanding logistics and potentially devastating complications is the centerpiece of a wide range of treatment-options provided by the DAZH. In endovascular techniques the DAZH offers unparalleled experience with fenestrated and branched treatment options for all segments of the aorta. New and innovative endovascular techniques to treat lesions of the aortic arch, thoraco-abdominal and thoracic aorta are developed in close collaboration with industrial partners.

Silesian Center for Heart Diseases (SCCS) in Zabrze, affiliated with Medical University of Silesia, is a Polish referral clinical and research center, specializing in prevention, diagnostics and treatment of heart, lung and vessel diseases for children and adults. Clinical profile: over 15.000 hospital admissions, over 12.000 cardiology procedures and more than 2400 open heart surgeries/per year. Leading in this part of Europe experience in aortic aneurysm treatment. Since 2005 until now 123 TEVAR cases; including hybrid arch procedures, acute dissections and 22 thoraco-abdominal open procedures performed also in Marfan patients, 19 EVAR.

SCCS is located in 4 modern hospital buildings. Its infrastructure includes departments of: cardiology (3), cardiovascular and endovascular surgery, heart and lung transplantation, anesthesiology wards, first in Poland (2011) state-of-the-art Severe Heart Failure and Mechanical Circulatory Support Ward, Cystic Fibrosis Ward, Hybrid Operating Room (5 ORs in total), 7 cardiovascular intervention labs (including 2 electrophysiology and electrotherapy labs) and well equipped modern diagnostic (magnetic resonance and CT scan) and treatment facilities. SCCS also has its own research and development center – Silesian Park of Medical Technology, with Artificial Heart Lab, Genomics, Experimental Research labs and an additional hybrid OR. This together with the SCCS teams know-how, vast experience and most-up-to date clinical program, makes SCCS a leading Polish center for cardiovascular disease treatment.

The University of Granada (UGR) is one of the largest and most important universities in Spain. UGR is located in the top 10 of Spanish universities by a variety of ranking criteria, and is one of the few Spanish Universities listed in the Shanghai Top 500 ranking (http://www.arwu.org/).

UGR will participate with the Department of Applied Economics in the PAPAartis study. The department has a strong interest in research in health economics and health technology assessment, with six permanent members of staff, two post-doctoral researchers, and six pre-doctoral students active in this area. In addition, the department has close links with health providers in Andalucía, and with the Andalusian School of Public Health in Granada, with whom we collaborate in research projects at local, national and international level, and provide courses in the evaluation of health technologies.

The European Clinical Research Infrastructure Network is a sustainable, not-for-profit, distributed infrastructure with the legal status of a European Research Infrastructure Consortium (ERIC).
ECRIN provides support to facilitate the development and implementation of multinational clinical research projects in Europe. Through its Core Team based in Paris and its European Correspondents based in various countries, ECRIN brings together national networks of academic clinical research infrastructures. These infrastructures are composed of Clinical Trials Units (CTU) and/or Clinical Research Centres (CRC) located in the main national universities and hospitals. The staff working in these units are experienced and professional, and are used to working with investigators and are very familiar with the local and national research environment.

ECRIN’s main activities can be characterised as follows:
i) Capacity building: supporting the development, both at national and pan-European level, of capacity to manage multinational trials in Europe. Specific activities include, among others: quality assurance; certification of partner centres; provision of regulatory and ethical expertise; development of common tools (e.g., monitoring strategies); training; and international cooperation.
ii) Operational support: coordinating the services of national partners (networks of CTUs) and certified data centres for improved cross-border collaboration.

The National Hospital Copenhagen is the largest hospital in Denmark, highly specialized and covers nearly all medical specialist areas. The hospital has a workload of endovascular aortic repair of approximately 130 cases/yearly, of these 30 are thoracic. Within the University, the Department of Clinical Medicine contributes to teaching, research and dissemination of knowledge within the clinical area. The department conducts pre- and postgraduate education of medical or scientific graduates in eastern Denmark. The Department counts academic staff of 200 clinical professors, almost 500 clinical associate professors, a number of clinical teachers and tutors, as well as about 700 PhD students.

The Heart Centre at the hospital is equipped with nationally and internationally recognised research environments, ensuring establishment of the latest international clinical and research-related results. Within the centre, the Department of Cardiothoracic Surgery has resources and capabilities to research: Lung and heart transplantation; Valve-preserving heart surgery; Surgical revascularisation without the use of a heart-lung machine as well as total arterial revascularization; Extra-corporal circulation (ECC); Heart Mate as a bridge to heart transplantation; Surgery for pectus excavatus and mesothelioma; Randomised studies focusing on ECC, haemorrhage, thrombosis and PCI versus CABG.

The European Society of Cardiology (ESC) represents over 87,000 cardiology professionals across Europe and the Mediterranean. Its mission is ''to reduce the burden of Cardiovascular Disease''. It comprises 6 Associations, 2 Councils, 16 Working Groups covering a wide variety of sub-specialities and 56 National Cardiac Societies in European and Mediterranean countries, all involved in the advancement of knowledge of diseases of the heart and circulation. It also organises the ESC Congress, the largest cardiovascular medical meeting worldwide and edits and publishes 7 of the world's leading journals on cardiology. It has an excellent track record for communicating and disseminating cardiology-related science to relevant audiences in Europe and across the globe.
Based at the European Heart House, Sophia Antipolis (France), the ESC publishes guidelines and recommendations for clinical practice, cardiology journals and other scientific publications; runs major conferences and educational programmes; and supports scientific endeavours across Europe and in all areas of cardiology.

With the European Heart Agency, the bureau in Brussels, the ESC supports the development of strong policies for the prevention of cardiovascular disease in the European Union.

Baylor College of Medicine is a health sciences university that creates knowledge and applies science and discoveries to further education, healthcare and community service locally and globally. Baylor is recognised as one of the most innovative Universities in the world. The Division of Cardiothoracic Surgery, led by Dr. Joseph S. Coselli, builds on the rich legacy of surgical innovators—Drs. Michael E. DeBakey, Denton A. Cooley, E. Stanley Crawford, and George P. Noon among others—who originated many of the 20th Century’s ground breaking aortic and cardiac surgical procedures. Today, Dr. Coselli, the world’s most experienced aortic surgeon with more than 7,500 aortic and over 3,300 thoracoabdominal aneurysm repairs to his credit, leads a world-renowned team of over 15 surgeons and researchers innovating strategies for the evaluation and treatment of diseases of the aorta and cardiovascular system. The cardiac surgery research team pursues several research projects and maintains one of the world’s most extensive and well-cataloged aortic tissue banks. This core resource facilitates investigations into the causes and progression of aortic disease pursued by our researchers, as well as researchers from other academic institutions. A growing portfolio of clinical and translational research efforts in the division, led by our (NIH-funded) vice-chair for research Dr. Scott A. LeMaire, includes more than 20 clinical studies in areas ranging from the genetics and molecular biology of aortic disease to applications of new heart valves and aortic grafts. Laboratory studies include the NIH-funded investigations of department chairman Dr. Todd K. Rosengart, whose research group is developing a means to use cellular reprogramming to convert cardiac scar tissue into new heart muscle.

The Trustees of the University of Pennsylvania Corp is a non-profit secondary and higher education institution. The University of Pennsylvania Health System, Thoracic Aortic Surgery Program was founded in 1993 by Joseph E. Bavaria, MD, President – Society of Thoracic Surgeons (STS), Brooke Roberts-William M. Measey Professor of Surgery, Vice-Chief, Division of Cardiovascular Surgery, Surgical Director, Heart and Vascular Center, Director, Thoracic Aortic Surgery Program. The aortic program is a multidisciplinary approach to the treatment complex cardio-aortic disease. Dr. Bavaria performs over 400 reconstructive procedures and manages in excess of 2500 patients in his outpatient clinic. His clinical practice includes patients with diseases and syndromes of the aorta such as Marfan’s Syndrome, aortic aneurysm and dissections, aortic arch management as well as valvular diseases such as bicuspid aortic stenosis and regurgitation. He is highly respected and one of distinct leaders in the world for the treatment of cardioaortic pathology. Dr. Bavaria’s interest also is well-known in the research arena being involved in pioneering technology which impact treatment paradigms and has open the doors for definitive surgical options for underserved population. His research interests range from basic science studying the microbiology and pathology of the aortic wall to the latest treatment for aortic stenosis with transcatheter valve clinical trial participation. He has successfully participated in multiple industry sponsored trials as national and local principle investigator. These trials are FDA IDE Early Feasibility Studies, Pivotal through Post-Market, FDA IND drug trials Phase I, II and III as well has NIH funding in the GenTac Study and CTSNetwork.

MODUS Research and Innovation Limited is a not for profit legal entity with the objective of facilitating collaborative research and innovation across the academic and business sectors. As an intermediary operating in the market space between business and academia, MODUS interacts with many R&D based businesses as well Universities and Research Institutes. In particular, MODUS offers expertise in planning for the exploitation of project results and the management of H2020 research and innovation projects. H2020 Project Management Support services cover all of the management and reporting requirements of the Commission allowing the coordinator to focus on leading the scientific and research aspects of the project. The MODUS team has over 14-years of experience managing Framework programmes. The management team all have scientific research backgrounds, and are trained in project management as well as H2020 requirements, ensuring that they can provide informed support in a wide variety of projects.

Marie Lannelongue Hospital (MLH) is located near the south of Paris. MLH is a non-profit association under the French law of 1901 (with a history of more than 100 years), dedicated to diagnosis and treatment of thoracic diseases (heart, lungs, vascular and major vessels) and meets the highest international levels of competence. MLH is the national centre of reference for management of severe pulmonary hypertension and tertiary referral centre for thoracic disease.

MLH hosts its own highly specialized research laboratories and collaborates daily with French research institutes (CEA, CNRS, INSERM, etc.) and the highest French engineering high schools (CentrleSupelec, Polytechnique, etc.) and the University.

They specifically host the INSERM U999 research unit "Pulmonary hypertension pathophysiology and innovative therapies".

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DFG-Funded Recruiting Sites

Since September 2017, PAPAartis corporates with 13 additional recruiting sites which allows the consortium to extend and improve the trial by roughly an additional 200 patients based on funding from the German Research Foundation (find more information here).