Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
139 participants
INTERVENTIONAL
2024-04-01
2028-04-01
Brief Summary
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Some patients may not be surgical candidates due to co-morbidities or because the vascular lesions are too distal making them technically inoperable. In these patients, balloon pulmonary angioplasty (BPA) has emerged as an effective treatment. In a subgroup of patients, the distribution of vascular lesions makes it possible to perform either BPA or PEA. There has never been a head-to head comparison of BPA with PEA. The aim of this study is therefore, to evaluate if BPA is non-inferior to PEA in patients with (CTEPH) who are eligible for both treatments.
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Detailed Description
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PEA or BPA will be completed within 6 months from randomization. Follow-up visit with right heart catheterization will be completed at 4 months and 12 months after PEA or last BPA session.
Primary end-point is change in pulmonary vascular resistance from baseline to 4 months and 12 months after PEA or the last BPA session.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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BPA group
Balloon pulmonary angioplasty. Typically 4-8 sessions are needed to treat the patient. The specific pre-planning protocol, choice of wires and balloons, the number of vessels treated per session, and the decision that no further BPA sessions are needed is at the discretion of the treating physician.
Balloon pulmonary angioplasty
Percutaneous balloon pulmonary angioplasty is performed using standard percutaneous technique to break the fibrotic clots in the pulmonary arteries using percutaneous transluminal angioplasty balloons.
PEA group
Patients randomized to PEA will undergo surgery within 4 months after randomization and optional run-in phase. Distality of the dissection plane is at the discretion of the operating physicians.
Pulmonary endarterectomy
Surgical pulmonary endarterectomy is done by a thoracic surgical procedure by removing chronic thrombotic material by intimal dissection with patient on cardiopulmonary bypass.
Interventions
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Pulmonary endarterectomy
Surgical pulmonary endarterectomy is done by a thoracic surgical procedure by removing chronic thrombotic material by intimal dissection with patient on cardiopulmonary bypass.
Balloon pulmonary angioplasty
Percutaneous balloon pulmonary angioplasty is performed using standard percutaneous technique to break the fibrotic clots in the pulmonary arteries using percutaneous transluminal angioplasty balloons.
Eligibility Criteria
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Inclusion Criteria
* Written informed consent from the patient
* Patient age \>17 and \<80 years
* Able to understand and follow instructions and to participate in the entire study period
Exclusion Criteria
* Co morbidities evaluated at the multidisciplinary team conference, that contributes significantly to the patients pulmonary hypertension
* Not possible to perform balloon pulmonary angioplasty or pulmonary endarterectomy within 4 months after randomization.
* Evaluated at multidisciplinary team conference that changes in pulmonary artery hypertension targeted therapy between baseline and 4 months follow-up is inevitable\*
* Known pregnancy or positive urine Human chorionic gonadotropin screening test in fertile women
* Previous balloon pulmonary angioplasty or pulmonary endarterectomy
18 Years
79 Years
ALL
No
Sponsors
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Kerckhoff Klinik
OTHER
Medical University of Vienna
OTHER
Papworth Hospital NHS Foundation Trust
OTHER_GOV
St. Antonius Hospital
OTHER
Utrecht University
OTHER
KU Leuven
OTHER
Amsterdam UMC, location VUmc
OTHER
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Irene Lang, MD,Prof
Role: STUDY_CHAIR
Medical University of Vienna
Harm Jan Bogaard, MD, Prof.
Role: STUDY_CHAIR
Amsterdam University Medical Center
Marion Delcroix, MD, Prof.
Role: STUDY_CHAIR
KU Leuven
Marco Post, MD, Prof.
Role: STUDY_CHAIR
St. Antonius Hospital
Gregely Meszaros, MD
Role: STUDY_CHAIR
Pulmonary Hypertension Association Europe
Johanna Pepke-Zaba, MD, Prof.
Role: STUDY_CHAIR
Papworth Hospital NHS Foundation Trust
Christoph Wiedenroth, MD
Role: STUDY_CHAIR
Kerckhoff Klinik
Locations
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Aarhus University Hospital
Aarhus, , Denmark
Royal Ppworth
Cambridge, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Asger Andersen, PhD
Role: primary
Joanna Pepke-Zaba
Role: primary
References
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Lang IM, Pesavento R, Bonderman D, Yuan JX. Risk factors and basic mechanisms of chronic thromboembolic pulmonary hypertension: a current understanding. Eur Respir J. 2013 Feb;41(2):462-8. doi: 10.1183/09031936.00049312. Epub 2012 Jun 14.
Gall H, Hoeper MM, Richter MJ, Cacheris W, Hinzmann B, Mayer E. An epidemiological analysis of the burden of chronic thromboembolic pulmonary hypertension in the USA, Europe and Japan. Eur Respir Rev. 2017 Mar 29;26(143):160121. doi: 10.1183/16000617.0121-2016. Print 2017 Mar 31.
Gerges C, Gerges M, Friewald R, Fesler P, Dorfmuller P, Sharma S, Karlocai K, Skoro-Sajer N, Jakowitsch J, Moser B, Taghavi S, Klepetko W, Lang IM. Microvascular Disease in Chronic Thromboembolic Pulmonary Hypertension: Hemodynamic Phenotyping and Histomorphometric Assessment. Circulation. 2020 Feb 4;141(5):376-386. doi: 10.1161/CIRCULATIONAHA.119.041515. Epub 2020 Jan 3.
Delcroix M, Vonk Noordegraaf A, Fadel E, Lang I, Simonneau G, Naeije R. Vascular and right ventricular remodelling in chronic thromboembolic pulmonary hypertension. Eur Respir J. 2013 Jan;41(1):224-32. doi: 10.1183/09031936.00047712. Epub 2012 Aug 16.
Riedel M, Stanek V, Widimsky J, Prerovsky I. Longterm follow-up of patients with pulmonary thromboembolism. Late prognosis and evolution of hemodynamic and respiratory data. Chest. 1982 Feb;81(2):151-8. doi: 10.1378/chest.81.2.151.
Galie N, Humbert M, Vachiery JL, Gibbs S, Lang I, Torbicki A, Simonneau G, Peacock A, Vonk Noordegraaf A, Beghetti M, Ghofrani A, Gomez Sanchez MA, Hansmann G, Klepetko W, Lancellotti P, Matucci M, McDonagh T, Pierard LA, Trindade PT, Zompatori M, Hoeper M. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: The Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS): Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC), International Society for Heart and Lung Transplantation (ISHLT). Eur Respir J. 2015 Oct;46(4):903-75. doi: 10.1183/13993003.01032-2015. Epub 2015 Aug 29.
Jenkins D, Madani M, Fadel E, D'Armini AM, Mayer E. Pulmonary endarterectomy in the management of chronic thromboembolic pulmonary hypertension. Eur Respir Rev. 2017 Mar 15;26(143):160111. doi: 10.1183/16000617.0111-2016. Print 2017 Jan.
Pepke-Zaba J, Delcroix M, Lang I, Mayer E, Jansa P, Ambroz D, Treacy C, D'Armini AM, Morsolini M, Snijder R, Bresser P, Torbicki A, Kristensen B, Lewczuk J, Simkova I, Barbera JA, de Perrot M, Hoeper MM, Gaine S, Speich R, Gomez-Sanchez MA, Kovacs G, Hamid AM, Jais X, Simonneau G. Chronic thromboembolic pulmonary hypertension (CTEPH): results from an international prospective registry. Circulation. 2011 Nov 1;124(18):1973-81. doi: 10.1161/CIRCULATIONAHA.110.015008. Epub 2011 Oct 3.
Lang I, Meyer BC, Ogo T, Matsubara H, Kurzyna M, Ghofrani HA, Mayer E, Brenot P. Balloon pulmonary angioplasty in chronic thromboembolic pulmonary hypertension. Eur Respir Rev. 2017 Mar 29;26(143):160119. doi: 10.1183/16000617.0119-2016. Print 2017 Mar 31.
Delcroix M, Lang I, Pepke-Zaba J, Jansa P, D'Armini AM, Snijder R, Bresser P, Torbicki A, Mellemkjaer S, Lewczuk J, Simkova I, Barbera JA, de Perrot M, Hoeper MM, Gaine S, Speich R, Gomez-Sanchez MA, Kovacs G, Jais X, Ambroz D, Treacy C, Morsolini M, Jenkins D, Lindner J, Dartevelle P, Mayer E, Simonneau G. Long-Term Outcome of Patients With Chronic Thromboembolic Pulmonary Hypertension: Results From an International Prospective Registry. Circulation. 2016 Mar 1;133(9):859-71. doi: 10.1161/CIRCULATIONAHA.115.016522. Epub 2016 Jan 29.
Khan MS, Amin E, Memon MM, Yamani N, Siddiqi TJ, Khan SU, Murad MH, Mookadam F, Figueredo VM, Doukky R, Benza RL, Krasuski RA. Meta-analysis of use of balloon pulmonary angioplasty in patients with inoperable chronic thromboembolic pulmonary hypertension. Int J Cardiol. 2019 Sep 15;291:134-139. doi: 10.1016/j.ijcard.2019.02.051. Epub 2019 Feb 23.
Tanabe N, Kawakami T, Satoh T, Matsubara H, Nakanishi N, Ogino H, Tamura Y, Tsujino I, Ogawa A, Sakao S, Nishizaki M, Ishida K, Ichimura Y, Yoshida M, Tatsumi K. Balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension: A systematic review. Respir Investig. 2018 Jul;56(4):332-341. doi: 10.1016/j.resinv.2018.03.004. Epub 2018 Jul 3.
Kim NH, Delcroix M, Jenkins DP, Channick R, Dartevelle P, Jansa P, Lang I, Madani MM, Ogino H, Pengo V, Mayer E. Chronic thromboembolic pulmonary hypertension. J Am Coll Cardiol. 2013 Dec 24;62(25 Suppl):D92-9. doi: 10.1016/j.jacc.2013.10.024.
Mayer E, Jenkins D, Lindner J, D'Armini A, Kloek J, Meyns B, Ilkjaer LB, Klepetko W, Delcroix M, Lang I, Pepke-Zaba J, Simonneau G, Dartevelle P. Surgical management and outcome of patients with chronic thromboembolic pulmonary hypertension: results from an international prospective registry. J Thorac Cardiovasc Surg. 2011 Mar;141(3):702-10. doi: 10.1016/j.jtcvs.2010.11.024.
Other Identifiers
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190580-0002
Identifier Type: -
Identifier Source: org_study_id
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