Clinical trial NCT00263263: RRISC Study: Reduction of Restenosis In Saphenous Vein Grafts With Cypher Sirolimus-Eluting Stent.
Official title: Phase 2 Randomized Double-Blind Comparison of Sirolimus-Eluting Stent Versus Bare-Metal Stent Implantation in Degenerated Saphenous Vein Grafts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stable Angina
Unstable Angina
Coronary Artery Disease
Saphenous Vein Graft Disease
Lead sponsor: Antwerp Cardiovascular Institute Middelheim
Sponsor class: OTHER
First posted: 2005-12-08
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* 18 to 85 years-old
* clear signs and/or symptoms of stable or unstable angina or documented silent ischemia
* one or more de-novo target lesions (\>50% diameter stenosis by visual estimate) localized in one or more diseased SVG with a reference vessel diameter (RVD) included between 2.5 and 4.0 mm (by visual estimate)
* signed informed consent.

Exclusion Criteria:

* Myocardial Infarction within the previous 7 days
* documented left ventricular ejection fraction \<25%
* impaired renal function (creatinine \>3.0 mg/dl) at the time of treatment
* outflow obstruction of the graft due to distal anastomotic stenosis
* totally occluded Saphenous Vein Graft
* brachytherapy treatment in the index vessel before enrollment
* life expectancy less than 12 months
* known allergy to aspirin, clopidogrel bisulfate, heparin, stainless steel, contrast agent or sirolimus
* hemorrhagic diatheses
* a recent positive pregnancy test, breast-feeding, or the possibility of a future pregnancy.

Primary outcomes:
measure: In-stent late loss
Secondary outcomes:
measure: in-segment late loss
measure: binary angiographic in-stent restenosis
measure: binary angiographic in-segment restenosis
measure: intravascular-ultrasound-measured neo-intimal hyperplasia volume
measure: death
measure: myocardial infarction
measure: target-lesion revascularization
measure: target-vessel revascularization
measure: stent thrombosis
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Antwerp Cardiovascular Institute Middelheim
Study officials:
affiliation: Antwerp Cardiovascular Institute Middelheim
name: Paul Vermeersch, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Antwerp Cardiovascular Institute Middelheim
name: Glenn Vanlangenhove, MD, PhD
role: STUDY_CHAIR
affiliation: Antwerp Cardiovascular Institute Middelheim
name: Pierfrancesco Agostoni, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.