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MeRes-1 Extend study is designed as prospective, multinational, multicentre, single arm, open label, pilot study to assess the safety and performance of the MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System (BRS) in subjects with de novo native coronary artery lesions. 64 subjects will be enrolled from the 8 centers located in Asia Pacific, Europe, Brazil and South Africa. Primary outcome of study will be Proportion of population reporting Major Adverse Cardiac Events at 6 months from the day of index Procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MeRes100 - BRS | Experimental | MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System | Device | MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System in the treatment of de-novo coronary artery lesions. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Clinical Endpoint: Proportion of population reporting with Major Adverse Cardiac Event at 6 months from the day of index procedure. | 6 Month | |
| Primary Safety Endpoint: Proportion of population reporting with Ischemia Driven Major Adverse Cardiac Event (ID MACE) reporting at 6 months (180 days) from the day of index procedure | 6 Month |
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Inclusion Criteria:
General Inclusion Criteria:
Angiographic Inclusion Criteria:
Exclusion Criteria:
General Exclusion Criteria:
Angiographic Exclusion Criteria:
Subjects who are non-candidates for PCI.
Any of the target lesions meets any of the following criteria:
Evidence of previous revascularization:
The target vessel contains visible thrombus.
Another (clinically significant or potentially significant) lesion left untreated within target vessels (including side branch) or another significant vessel.
Subject requiring or potentially requiring interventional procedures other than pre-dilatation and study device implantation and post dilatation.
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Alexandre Abizaid | Dante Pazzanese Hospital, Sao Paulo, Brazil | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Dante Pazzanese de Cardiologia | São Paulo | São Paulo | 04012-909 | Brazil | ||
| Medistra Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33269506 | Derived | Abizaid A, Kedev S, Ali RBM, Santoso T, Cequier A, van Geuns RVG, Chevalier B, Hellig F, Costa R, Onuma Y, Costa JR Jr, Serruys P, Bangalore S. Imaging and 2-year clinical outcomes of thin strut sirolimus-eluting bioresorbable vascular scaffold: The MeRes-1 extend trial. Catheter Cardiovasc Interv. 2021 Nov 15;98(6):1102-1110. doi: 10.1002/ccd.29396. Epub 2020 Dec 2. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Single intervention with MeRes100 Device
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| Jakarta |
| 12950 |
| Indonesia |
| Institut Jantung Negara | Kuala Lumpur | 50400 | Malaysia |
| University Clinic of Cardiology | Skopje | 1000 | North Macedonia |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |