PROVIDENCE:Prevention of Restenosis With Oral Rosiglitazone and the Vision Stent in Diabetics With Coronary Lesions

NCT ID: NCT00116792

Last Updated: 2007-05-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-03-31

Brief Summary

We hypothesize that the combination of the thin-strut MULTI-LINK (i.e. VISION(tm) and/or MINI-VISION(tm)) stent and pharmacologic therapy with the oral PPAR-gamma agonist rosiglitazone will significantly reduce restenosis after intracoronary stenting in type 2 diabetic patients. This approach would present a more effective and economical alternative to the use of drug-eluting stents to reduce stent restenosis.

Conditions

Coronary Artery Disease; Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

Percutaneous Coronary Intervention (PCI)

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• The patients must be >18 years of age;
• Patients must be previously diagnosed with type 2 diabetes with documented treatment with insulin, oral hypoglycemics, or diet controlled by medical history. (Undocumented or newly diagnosed diabetics must fulfill the American Diabetes Association Criteria-Report of the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus (Diabetes Care 2003;26:S5-20)).
• Diagnosis of angina pectoris defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B&C, I-II-III) OR patients with documented silent ischemia;
• Treatment of lesions in native coronary arteries requiring stenting. A total of two separate lesions can be stented, located either in the same vessel (at least 10 mm or 1 cm apart) or in two separate vessels. Additional stents may be used for procedural complications such as dissections.
• Patient is willing to comply with the specified follow-up evaluation;
• Patient must provide written informed consent prior to the procedure using a form that is approved by the local Institutional Review Board.
• Target lesion is ≥2.0 mm to ≤3.5mm in diameter (visual estimate);
• Individual lesions are ≤25 mm in length located in a native coronary artery;
• Target lesions are de novo lesions in native coronary vessels;
• Target lesion stenosis is ≥50% and <100% (visual estimate);

Exclusion Criteria

• Patient has experienced an ST-segment elevation myocardial infarction within the preceding 24 hours.
• Ejection fraction ≤40%; class III-IV CHF
• Active liver disease (ALT>2.5 times upper limit of normal)
• Woman of child-bearing potential unless demonstrated 1) negative pregnancy test and 2) clear intention of an accepted method of contraception for eight months after enrollment
• Totally occluded vessel (TIMI 0 grade flow);
• Impaired renal function (creatinine ≥2.5 mg/dL);
• Target lesion involves bifurcation including a side branch ≥2.5 mm in diameter (either stenosis of both main vessel and major branch or stenosis of just major branch) that would require side branch stenting which is likely to occur if side branch is diseased and intended to be stented;
• Previous brachytherapy of target vessel;
• Recipient of heart transplant;
• Patient with a life expectancy less than 12 months;
• Known allergies to cobalt, chromium, nickel, aspirin, clopidogrel bisulfate (Plavix®) and/or ticlopidine (Ticlid®), heparin, and/or rosiglitazone (Avandia®), that cannot be medically managed;
• Any significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study;
• Currently participating in an investigational drug or another device study;
• Any contraindication to glycoprotein IIb/IIIa inhibitor therapy;
• Current use of any TZD, i.e. rosiglitazone (Avandia®) or pioglitazone (Actos®)
• Chronic or relapse/remitting hemolytic condition
• Unprotected left main coronary disease with >50% stenosis;
• Patients admitted for treatment of diabetic ketoacidosis >2 times in the past six months (brittle diabetics) and/or the suspicion of type I diabetes;
• Target lesion is in a saphenous venous graft or internal mammary graft;
• Target lesion is due to restenosis
• 3 vessel coronary artery disease defined as ≥70% ischemia producing lesions in 3 different epicardial coronary arteries all requiring revascularization (i.e. main left main equivalent)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guidant Corporation

INDUSTRY

Sponsor Role: collaborator

Gold, Herman K., MD

INDIV

Sponsor Role: lead

Principal Investigators

Herman K Gold, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2003P-001717

Identifier Type: -

Identifier Source: org_study_id