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The objective of this study is to assess the performance and safety of a sirolimus-eluting, heparin-coated, cobalt chromium balloon-expandable stent (Small Vessel Stent) in patients with de novo native coronary artery lesions in small vessels as compared to historical data from small vessel patients in the RAVEL trial receiving the Sirolimus-eluting Bx VELOCITYâ„¢ stent.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SIROLIMUS-ELUTING, HEPARIN-COATED CoCr BALLOON-EXPANDABLE STENT | Device |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint is in-stent late loss as measured by quantitative coronary angiography (QCA) at 6 months post-procedure. | 6 months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| In-lesion late loss as measured by QCA at 6 months post-procedure. | 6 months post-procedure | |
| In-stent and in-lesion minimum lumen diameter (MLD) and percent diameter stenosis (%DS) by QCA post-procedure and at 6 months. | Post-procedure and at 6 months |
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Inclusion Criteria:
3 Treatment of one lesion in a native coronary artery. The treated lesion will be the one with the highest % diameter stenosis by visual estimate. Additional study stents may be used for procedural complications such as dissections. Multivessel treatment is permissible in non-target vessels; however, additional lesions may only be treated with commercial stents. If other non-target vessels are treated with commercial stents during the index procedure, they must be successfully treated prior to the study lesion;
4. The target lesion is >/=2.0 mm and </=2.5mm in diameter (visual estimate);
5. The target lesion can be covered with a single 18mm stent;
6. Target lesion stenosis is >50% and <100% (TIMI I) (visual estimate);
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J. E. Sousa, MD | Instituto Dante Pazzanese de Cardiologia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Dante Pazzanese de Cardiologia | São Paulo | Brazil |
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| Device success defined as achievement of a final residual diameter stenosis of <50% (by QCA), using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used. |
| Target Lesion Revascularization (TLR) at six and 12 months. | 6 and 12 months |
| Target Vessel Revascularization (TVR) at six and 12 months. | 6 and 12 months |
| Composite of Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target lesion revascularization at 30 days, 6 months and 12 months post-procedure. | 30 days, 6 months and 12 months post-procedure |
| Stent Lumen and Stent Obstruction Volume by Intravascular Ultrasound (IVUS) at post procedure and six months follow-up. | post procedure and six months |
| 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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