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Context: Sirolimus-eluting-stents have improved the benefits of percutaneous interventions in native coronary arteries reducing the occurrence of restenosis and repeated revascularization, however saphenous vein grafts have been always excluded form randomized trials.
Objective: To evaluate the angiographic and clinical impact of sirolimus-eluting-stents with respect to bare-metal-stents in degenerated vein grafts.
Design: Double-blind randomized controlled non-industry-sponsored trial.
Setting: A single-center tertiary-care referral hospital.
Patients: All patients are randomly allocated to sirolimus-eluting-stent implantation or the corresponding bare-metal-stent. All patients are followed clinically and repeated angiographic follow-up is performed in all at 6-months.
Main outcome measure: Primary end-point is 6-months angiographic in-stent late loss. Secondary end-points include: binary angiographic in-stent and in-segment restenosis, intravascular-ultrasound-measured neo-intimal hyperplasia volume and all the clinical events (death, myocardial infarction, target-lesion and target-vessel revascularization).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sirolimus-eluting stent | Device | |||
| bare metal stent | Device |
| Measure | Description | Time Frame |
|---|---|---|
| In-stent late loss |
| Measure | Description | Time Frame |
|---|---|---|
| in-segment late loss | ||
| binary angiographic in-stent restenosis | ||
| binary angiographic in-segment restenosis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Vermeersch, MD | Antwerp Cardiovascular Institute Middelheim | Principal Investigator |
| Glenn Vanlangenhove, MD, PhD | Antwerp Cardiovascular Institute Middelheim | Study Chair |
| Pierfrancesco Agostoni, MD | Antwerp Cardiovascular Institute Middelheim | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antwerp Cardiovascular Institute Middelheim | Antwerp | 2020 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17631219 | Derived | Vermeersch P, Agostoni P, Verheye S, Van den Heuvel P, Convens C, Van den Branden F, Van Langenhove G; DELAYED RRISC (Death and Events at Long-term follow-up AnalYsis: Extended Duration of the Reduction of Restenosis In Saphenous vein grafts with Cypher stent) Investigators. Increased late mortality after sirolimus-eluting stents versus bare-metal stents in diseased saphenous vein grafts: results from the randomized DELAYED RRISC Trial. J Am Coll Cardiol. 2007 Jul 17;50(3):261-7. doi: 10.1016/j.jacc.2007.05.010. Epub 2007 Jun 13. | |
| 17174178 |
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| intravascular-ultrasound-measured neo-intimal hyperplasia volume |
| death |
| myocardial infarction |
| target-lesion revascularization |
| target-vessel revascularization |
| stent thrombosis |
| Derived |
| Vermeersch P, Agostoni P, Verheye S, Van den Heuvel P, Convens C, Bruining N, Van den Branden F, Van Langenhove G. Randomized double-blind comparison of sirolimus-eluting stent versus bare-metal stent implantation in diseased saphenous vein grafts: six-month angiographic, intravascular ultrasound, and clinical follow-up of the RRISC Trial. J Am Coll Cardiol. 2006 Dec 19;48(12):2423-31. doi: 10.1016/j.jacc.2006.09.021. Epub 2006 Nov 28. |
| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| D000789 | Angina, Unstable |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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