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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00263263
First Posted: December 8, 2005
Last Update Posted: March 14, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Antwerp Cardiovascular Institute Middelheim
  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
Intervention Model: Parallel Assignment
Masking: Double
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: December 7, 2005
First Posted: December 8, 2005
Last Update Posted: March 14, 2007
Last Verified: March 2007

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