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Prospective, multi-center, randomized 1:1, single blind trial using BuMA Supreme versus Resolute Integrity conducted in approximately 14 interventional cardiology centers in The Netherlands, Belgium, Spain and Portugal.
Clinical follow-up will occur at 1, 9 and 12 months post-stent implantation. All patients will undergo repeat angiography at 9 months follow-up. QCA assessment will be performed at baseline (pre- and post-procedure) and at 9 months follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BuMA Supreme Biodegradable drug coating coronary stent system | Experimental | Implant BuMA Supreme stent only |
|
| Resolute Integrity durable polymer stent system | Active Comparator | Implant Resolute stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BuMA Supreme Biodegradable drug coating coronary stent system | Device |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Late Lumen Loss | The primary endpoint is in-stent Late Lumen Loss (LLL) at 9 months after stent implantation as assessed by off-line QCA. | Up to 9 month |
| Measure | Description | Time Frame |
|---|---|---|
| Angiographic endpoint | Acute Lumen Gain (mm); | 9 and 12 month |
| Angiographic endpoint | MLD (mm) post procedure and at 9 months; | 9 and 12 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clemens von.Birgelen, MD,Phd | Medisch Spectrum Twente (MST), Enschede, the Netherlands | Principal Investigator |
| Manel Sabate, MD,Phd | Clinic university hospital Barcelona, Spain | Principal Investigator |
| Patrick W.Serruys, MD,Phd | Interventional Cardiology, Thorax center, Erasmus MC, Rotterdam | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imelda Hospital | Bonheiden | Belgium | ||||
| CHU Chaleroi |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34666500 | Derived | Wang R, Kawashima H, Hara H, Gao C, Ono M, Takahashi K, Tu S, Soliman O, Garg S, van Geuns RJ, Tao L, Wijns W, Onuma Y, Serruys PW. Comparison of Clinically Adjudicated Versus Flow-Based Adjudication of Revascularization Events in Randomized Controlled Trials. Circ Cardiovasc Qual Outcomes. 2021 Nov;14(11):e008055. doi: 10.1161/CIRCOUTCOMES.121.008055. Epub 2021 Oct 20. |
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| Resolute Integrity durable polymer stent system |
| Device |
|
| Angiographic endpoint | Diameter Stenosis (%) post procedure and at 9 months; | 9 and 12 month |
| Angiographic endpoint | Binary Restenosis (DS ≥50%) at 9 months | 9 and 12 month |
| Clinical endpoint | Acute success (device and procedural success) | 9 and 12 month |
| Cinical endpoint | Device-oriented Composite Endpoints (DoCE) at 1, 9 and 12 months and its individual components. (Device-oriented Composite Endpoint is defined as Cardiac Death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated Target Lesion Revascularization). | 9 and 12 month |
| Clinical endpoint | Myocardial infarction (Q-wave, Non q-wave) at all time points. | 9 and 12 month |
| Clinical endpoint | Any revascularization at all time points. | 9 and 12 month |
| Clinical endpoint | Stent thrombosis according to the ARC definitions up to 12 months follow-up. | 9 and 12 month |
| Chaleroi |
| Belgium |
| Oost-limburg Hospital | Genk | Belgium |
| AMC | Amsterdam | Netherlands |
| OLVG | Amsterdam | Netherlands |
| UMCG | Groningen | Netherlands |
| Maasstad Hospital | Rotterdam | Netherlands |
| Hospita; Garcia de Orta | Almada | Portugal |
| Santa Maria University Hospital | Lisbon | Portugal |
| Gaia/Espinho Hospital Centers | Porto | Portugal |
| University Hospital Madrid | Madrid | Spain |
| Hospital Álvaro Cunqueiro | Vigo | Spain |
| 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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