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

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ClinicalTrials.gov Identifier: NCT00116792
Recruitment Status : Unknown
Verified May 2007 by Gold, Herman K., MD.
Recruitment status was:  Active, not recruiting
First Posted : July 1, 2005
Last Update Posted : May 17, 2007
Guidant Corporation
Information provided by:
Gold, Herman K., MD

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Diabetes Mellitus Procedure: Percutaneous Coronary Intervention (PCI) Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: PROVIDENCE: Prevention of Restenosis With Oral Rosiglitazone and the Vision Stent in Diabetics With de Novo Coronary Lesions
Study Start Date : March 2004

Primary Outcome Measures :
  1. In-stent and In-segment late lumen loss

Secondary Outcome Measures :
  1. In-stent mean percent diameter stenosis (%DS) and binary restenosis as measured by QCA at post-procedure and at 8 months
  2. TLR and TVR at 30 days, and 8 months post procedure
  3. TVF defined as cardiac death, MI, or TVR at 30 days, 8 months and l year post-procedure
  4. Composite of Major Adverse Cardiac Events (MACE)
  5. The association of metabolic factors and inflammatory indices including glycemia (HgbA1C), diabetic therapy other than TZDs, HSCRP, coagulation (PAI-1, FIB) and inflammatory marker levels (ADI, MPO, &MMP-9) with the risk for restenosis
  6. Target HgbA1C≤7 for all patients enrolled
  7. Coronary artery stenosis progression in at least one non-stented lesion
  8. Coronary artery stenosis regression in at least one non-stented lesion
  9. Culprit (i.e. stented artery) artery stenosis progression/regression by intravascular ultrasound (IVUS)
  10. (There are 3 more secondary endpoints not listed here.)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

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): NCT00116792

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Gold, Herman K., MD
Guidant Corporation
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Principal Investigator: Herman K Gold, MD Massachusetts General Hospital
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ClinicalTrials.gov Identifier: NCT00116792    
Other Study ID Numbers: 2003P-001717
First Posted: July 1, 2005    Key Record Dates
Last Update Posted: May 17, 2007
Last Verified: May 2007
Keywords provided by Gold, Herman K., MD:
Diabetes Mellitus
ppar gamma
Additional relevant MeSH terms:
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Coronary Artery Disease
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases