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The objective of this study is to assess the performance and safety of a formulation of the antiproliferative agent, sirolimus coated on modified Bx VELOCITY Balloon-Expandable Stent mounted on the Raptor Over The Wire (OTW) Stent Delivery System (SDS) in patients with de novo coronary artery lesions.
This is a single center, non-randomized study. Patients who meet the eligibility criteria will be treated with the sirolimus coated modified Bx VELOCITY Balloon-Expandable Stent mounted on the Raptor OTW SDS. Patients will be followed for five years post-procedure, with all patients having a repeat angiography at 6 months, 18 months, and 48 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sirolimus-coated Bx VELOCITY Stent | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of in-stent percent diameter stenosis (%DS) measured by quantitative coronary angiography. | post procedure and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of lesion morphology by intravascular ultrasound (IVUS). | post procedure and 6 months | |
| Target vessel failure (TVF). | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick W Serruys, MD | Erasmus Centrum Thoraxcentrum | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus Centrum Thoraxcentrum | Rotterdam | NL- 3015 GD | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11686669 | Result | Rensing BJ, Vos J, Smits PC, Foley DP, van den Brand MJ, van der Giessen WJ, de Feijter PJ, Serruys PW. Coronary restenosis elimination with a sirolimus eluting stent: first European human experience with 6-month angiographic and intravascular ultrasonic follow-up. Eur Heart J. 2001 Nov;22(22):2125-30. doi: 10.1053/euhj.2001.2892. | |
| 12270850 |
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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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| Degertekin M, Serruys PW, Foley DP, Tanabe K, Regar E, Vos J, Smits PC, van der Giessen WJ, van den Brand M, de Feyter P, Popma JJ. Persistent inhibition of neointimal hyperplasia after sirolimus-eluting stent implantation: long-term (up to 2 years) clinical, angiographic, and intravascular ultrasound follow-up. Circulation. 2002 Sep 24;106(13):1610-3. doi: 10.1161/01.cir.0000034447.02535.d5. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |