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A prospective, active control, open-label, multinational, randomized clinical trial comparing single long BioMime™ Morph Coronary Stent System vs. two overlapping Xience family Coronary Stent Systems to evaluate safety and performance in approximately 200 patients with long de novo lesions will be randomly enrolled in a 2:1 ratio [BioMime™ Morph (n=133) vs. XIENCE family (n=67)].
The study population should include patients with symptomatic ischemic heart disease due to de novo lesions (lengths ≥26 mm and ≤56 mm irrespective of number of lesions) in native coronary arteries with a reference vessel diameter of (proximal to distal) 2.75 - 2.25 mm, 3.00 - 2.50 mm and 3.5 - 3.00 mm in patients eligible for Percutaneous Transluminal Coronary Angioplasty (PTCA) and stenting procedures.
All patients must meet all the study inclusion / exclusion criteria before enrolment in the study. All subjects shall accept clinical follow up at 1 month, 6 months, 12 months, 24 months post procedure.
10% of the patients [(2:1) BioMime™ Morph (13) vs. Xience (7)] will be assessed for OCT analysis from pre-designated site(s) and based on availability of OCT console at the site and Patient's consent. [Time Frame: Post-procedure and 6 months (±14 days)]
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BioMime™ Morph - Sirolimus Eluting Coronary Stent System | Experimental |
| |
| Xience family Everolimus Coronary Stent Systems | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioMime™ Morph - Sirolimus Eluting Coronary Stent System | Device | Study Device :- BioMime™ Morph - Sirolimus Eluting Coronary Stent System Approximately 200 patients will be randomly enrolled in a 2:1 ratio [BioMime™ Morph (n=133) vs. XIENCE family (n=67)]. |
| Measure | Description | Time Frame |
|---|---|---|
| Target Lesion Failure (TLF) | Target lesion failure is defined as a composite of cardiac death, myocardial infarction attributed to target vessel or Ischemia-driven target lesion revascularization. | 6 months (±14 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Target Lesion Failure | Target lesion failure is defined as a composite of cardiac death, myocardial infarction attributed to target vessel or ischemia-driven target lesion revascularization. | 1 month (± 7 days), 12 months (±1 month) and 24 months (±1 month) |
| MACE |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Success | On a per patient basis, technical success without complications within 48 hours after the index procedure or at hospital discharge, whichever is sooner. | Within 48 hours after the index procedure or at hospital discharge, whichever is sooner |
| User ratings on technical properties |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ashok Thakkar, Ph.D | Contact | 9879443584 | ashok.thakkar@merillife.com | |
| Mr. Kartik Vyas | Contact | 9619129010 | kartik.vyas@merillife.in |
| Name | Affiliation | Role |
|---|---|---|
| Dr. Ertugrul Okuyan | Bagcilar Egitim ve Arastirma Hastanesi | Principal Investigator |
| Dr. Omer Kozan | Siyami Ersek Gogus Kalp ve Damar Cerrahisi Egitim ve Arastirma Hastanesi | Principal Investigator |
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Study Device :- BioMime™ Morph - Sirolimus Eluting Coronary Stent System Active Control Device :- Xience family Everolimus Coronary Stent Systems
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| Xience family Everolimus Coronary Stent Systems | Device | Active Control Device :- Xience family Everolimus Coronary Stent Systems Approximately 200 patients will be randomly enrolled in a 2:1 ratio [BioMime™ Morph (n=133) vs. XIENCE family (n=67)]. |
|
Major adverse cardiac event is defined as a composite of cardiac death, myocardial infarction attributed to the target vessel or Ischemia-driven Target Lesion Revascularization (ID-TLR). |
| 1 month (± 7 days), 6 months (±14 days), 12 months (±1 month) and 24 months (±1 month) |
| Stent Thrombosis Rate (As per Academic Research Consortium) | Stent thrombosis is defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers, probable (any unexplained death within the first 30 days), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis is categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation). | 1 month (± 7 days), 6 months (±14 days), 12 months (±1 month) and 24 months (±1 month) |
| Ischemia-driven Target Vessel Revascularization (ID-TVR) | Ischemia-driven Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | 1 month (± 7 days), 6 months (±14 days), 12 months (±1 month) and 24 months (±1 month) |
User's satisfaction Rating on a scale of 0 - 5 on the parameters of the coronary listed below: a) Flexibility b) Pushability c) Trackability d) Crossability e) Inflation time f) Deflation time g) Ease of removal h) Radiopaque marker visibility (Where 0=very poor comfort, 1=poor comfort, 2=below average, 3=average, 4=good and 5=excellent). |
| Baseline] |
| Dr. Jan - Peter V Kuijk | St. Antonius Hospital | Principal Investigator |
| Dr. Jakub Podolec | Krakowski Szpital Specjalistyczny im. Jana Pawla II | Principal Investigator |
| Dr. Andrzej Ochala | Zaklad Kardiologii Inwazyjnej | Principal Investigator |
| Dr. Oleg Polonetsky | National Scientific and Practical Centre - Cardiology | Principal Investigator |
| Dr. Orazbek Sakhov | City Heart Center | Principal Investigator |
| 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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