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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-005353-67 | EudraCT Number |
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meriT-V is a Prospective,active control open lable clinical trial to compare safety & efficacy of BioMime Sirolimus stent Vs. Xience family of Everolimus stent by random assignment for treatment of coronary artery disease at multiple multinational centres.
This study is conducted to evaluate the multicenter investigation comparing the BioMime Sirolimus Drug Eluting stent with XIENCE family of (Abbott Vascular, Santa Clara, California, USA) in the treatment of patients with coronary artery disease. Considering that the randomized studies provide a better comparability and a real efficacy and safety data of the devices. Subjects will be randomized 2:1 with surrogate endpoints and clinical evaluation.
Subject included in study are eligible to meet the inclusion and exclusion criteria of the study protocol .The informed consent process will be performed before the subject underwent for the Procedure. Subject will be treated with treatment allocated by the process of Randomization. The study follow up will be Seattle angina score evaluation up to 2 years after the procedure of angioplasty along with the Hospital or telephonic follow up at 1 Month 5month ,1 and 2 years and angiographic follow up at 9 Month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sirolimus Eluting Coronary Stent | Experimental | BioMime Sirolimus Eluting Stent of Meril Life Sciences |
|
| Everolimus-eluting Coronary stent | Active Comparator | XIENCE family (V, Xpedition or Prime) of Everolimus-eluting stent system of Abbott Vascular Inc. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sirolimus Eluting Coronary Stent | Device | BioMimeTM Sirolimus Eluting Stent (CE Marked) has cobalt chromium NexGenTM platform (CE Marked) with Tamarin BlueTM balloon Delivery System (CE marked and with FDA clearance under 510k). Stent is coated with combination of Sirolimus drug and Biodegradable PLLA and PDLG polymers. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess in-stent Late Lumen Loss | The primary outcome of this study is to assess in-stent Late Lumen Loss at 9 months for both treatment strategies. | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Binary restenosis by Angiography | Binary Restenosis (DS ≥50%) | 9 months |
| Minimum Lumen Diameter by Angiography | MLD and %DS post procedure at 9 months as compared with pre procedure baseline and post procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Alexandre Abizaid, Ph.D, MD | Instituto Dante Pazzanese de Cardiologia | Principal Investigator |
| Dr. Roberto V Botelho, MD | Instituto do Coracao do Triangulo Mineiro | Principal Investigator |
| Dr. Pedro Lemos, MD | Instituto do Coracao - HCFMUSP Centro de Pesquisa Clinica | Principal Investigator |
| Dr. Expedito Ribeiro, MD | Instituto do Coracao - HCFMUSP Centro de Pesquisa Clinica | Principal Investigator |
| Dr. Elvin Kedhi, Ph.D, MBBS | Isala | Principal Investigator |
| Dr. Pim Tonino, MD | Catharina Cardiac Centre | Principal Investigator |
| Dr. Floris Kauer, MD | Albert Schweitzer | Principal Investigator |
| Dr. Luc Janssen, MD | Imelda Ziekenhuis Cardiology | Principal Investigator |
| Dr. Farzin F Ordoubadi, B.Sc, MB BCHIR, MRCP, MD, FRCP | Manchester Heart Centre |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imelda Ziekenhuis Cardiology | Bonheiden | Western Europe | 2820 | Belgium | ||
| Instituto Dante Pazzanese de Cardiologia |
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BioMime Sirolimus Eluting Stent system compared to the Abbott XIENCE family (V, Xpedition or Prime) of Everolimus Eluting Stent system
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Open label
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| Everolimus-eluting Coronary stent | Device | Xience V/Xience Xpedition/Xience Prime stent is MULTI-LINK MINI VISION or MULTI-LINK VISION platform Cobalt chromium stent with Everolimus (active ingredient) embedded in a non-erodible polymer (inactive ingredient). |
|
|
| 9 months |
| In-segment Late Lumen Loss at 9 months | In-segment Late Lumen Loss at 9 months in-segment and proximal and distal stent margins. | 9 months |
| Clinical Evaluation | Major Adverse Cardiac Events (MACE) | 1, 5, 9, 12 and 24 months |
| Dr. Suneel Talwar, MBBS, MRCP, MD | Royal Bournemouth Hospital | Principal Investigator |
| Dr. Monica Masotti, MD | Hospital Clinic | Principal Investigator |
| Dr. Andrejs Erglis, MD | University of Latvia, Research Institute of Cardiology | Principal Investigator |
| Prof. Sasko Kedev, Ph.D, MD, FESC, FACC | University Clinic of Cardiology | Principal Investigator |
| Dr. Ota Hlinomaz, Ph.D, MD | St. Anne's Univeristy Hospital Brno | Principal Investigator |
| Dr. Petr kala, Ph.D, MD, FESC, FSCAI | Fn Brno, Jihlavska 20 | Principal Investigator |
| Dr. Krzysztof Milewski, Ph.D, MD | American Heart Institure S.A. | Principal Investigator |
| São Paulo |
| 04012-909 |
| Brazil |
| Instituto do Coracao - HCFMUSP Centro de Pesquisa Clinica | São Paulo | 05403-000 | Brazil |
| Instituto do Coracao do Triangulo Mineiro | Uberlândia | 38411-186 | Brazil |
| St. Anne's Univeristy Hospital Brno | Brno-střed | Brno | 656 91 | Czechia |
| Fn Brno, Jihlavska 20 | Brno | 602 00 | Czechia |
| University of Latvia, Research Institute of Cardiology | Riga | Europe | LV1002 | Latvia |
| Catharina Cardiac Centre | Eindhoven | North Brabant | 5623 | Netherlands |
| Albert Schweitzer | Dordrecht | South Holland | 3300 | Netherlands |
| Isala Hospital | Zwolle | 8025 | Netherlands |
| University Clinic of Cardiology | Skopje | 1000 | North Macedonia |
| American Heart Institure S.A. | Tychy | Silesian Voivodeship | 43-100 | Poland |
| Hospital Clinic | Barcelona | Catalonia | 08036 | Spain |
| Royal Bournemouth Hospital | Bournemouth | England | BH7 7DW | United Kingdom |
| Manchester Heart Centre | Manchester | England | M13 9WL. | United Kingdom |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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