RRISC Study: Reduction of Restenosis In Saphenous Vein Grafts With Cypher Sirolimus-Eluting Stent.

This study has been completed.
Sponsor:
Information provided by:
Antwerp Cardiovascular Institute Middelheim
ClinicalTrials.gov Identifier:
NCT00263263
First received: December 7, 2005
Last updated: March 12, 2007
Last verified: March 2007
  Purpose

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).


Condition Intervention Phase
Stable Angina
Unstable Angina
Coronary Artery Disease
Saphenous Vein Graft Disease
Device: sirolimus-eluting stent
Device: bare metal stent
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Phase 2 Randomized Double-Blind Comparison of Sirolimus-Eluting Stent Versus Bare-Metal Stent Implantation in Degenerated Saphenous Vein Grafts

Resource links provided by NLM:


Further study details as provided by Antwerp Cardiovascular Institute Middelheim:

Primary Outcome Measures:
  • In-stent late loss

Secondary Outcome Measures:
  • in-segment late loss
  • binary angiographic in-stent restenosis
  • binary angiographic in-segment restenosis
  • intravascular-ultrasound-measured neo-intimal hyperplasia volume
  • death
  • myocardial infarction
  • target-lesion revascularization
  • target-vessel revascularization
  • stent thrombosis

Estimated Enrollment: 75
Study Start Date: September 2003
Estimated Study Completion Date: December 2005
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00263263

Locations
Belgium
Antwerp Cardiovascular Institute Middelheim
Antwerp, Belgium, 2020
Sponsors and Collaborators
Antwerp Cardiovascular Institute Middelheim
Investigators
Principal Investigator: Paul Vermeersch, MD Antwerp Cardiovascular Institute Middelheim
Study Chair: Glenn Vanlangenhove, MD, PhD Antwerp Cardiovascular Institute Middelheim
Study Director: Pierfrancesco Agostoni, MD Antwerp Cardiovascular Institute Middelheim
  More Information

No publications provided by Antwerp Cardiovascular Institute Middelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00263263     History of Changes
Other Study ID Numbers: INCUBATE-001
Study First Received: December 7, 2005
Last Updated: March 12, 2007
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

Additional relevant MeSH terms:
Angina Pectoris
Angina, Unstable
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases
Sirolimus
Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 29, 2014