Diabetes Drug Eluting Sirolimus Stent Experience in Restenosis Trial

NCT00497172 | Completed Phase 4 DMC

• 1 other identifier: CRDIT 00-02/02
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to assess the safety and effectiveness of the Sirolimus-eluting stent CYPHERTM and/or updated version in reducing angiographic in-stent late loss in de novo native coronary lesions of diabetic patients as compared to the bare metal Bx SONIC balloon-expandable stent. The secondary objective is to assess cost-effectiveness expressed in incremental cost/life year gained or cost/quality adjusted life year gained at different time points (8 months, 1 year).

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• in-stent LL

  8-month post-procedure

Secondary Outcomes (3)

• MACE

  1, 9, and 12 Months

• Target vessel failure

  12 months

• Target lesion or target vessel revascularization

  12 months

Study Arms (2)

1

EXPERIMENTAL

drug-eluting stent

Device: CYPHER Sirolimus-eluting stent

2

ACTIVE COMPARATOR

bare-metal stent

Device: Bx SONIC bare metal stent

Interventions

CYPHER Sirolimus-eluting stent DEVICE

drug-eluting stent

1

Bx SONIC bare metal stent DEVICE

bare-metal stent

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient must be ≥ 18 years of age;
• Female of childbearing potential must have a negative pregnancy test within 7days of enrollment and utilize reliable birth control for eight months after enrollment;
• Patients with IDDM (Type I) treated for at least 3 months with documented HbA1c, or NIDDM (Type II) treated with oral antidiabetics for at least 3 months;
• Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B\&C, I-II) OR patients with documented silent ischemia OR patient with previous (\>24 hours) myocardial infarction with documented residual ischemia and/or viable myocardium;
• Single or double stent treatment of de novo lesion in a major coronary artery in patients with single or multi-vessel disease; patients with multi-vessel disease can be included only if a maximum of two vessels require treatment with a maximum of three lesions in total, no more than two lesions per vessels. The two lesions in a single vessel must be \>10 mm apart (visual estimate) and must be treated with the assigned stent.
• Target vessel diameter at the lesion site is ≥ 2.50mm and ≤ 3.5mm in diameter (visual estimate);
• Target lesion is ≥ 13mm and ≤ 25mm in length (visual estimate);
• Target lesion stenosis is \>50% and \<100% (visual estimate);
• At least TIMI II coronary flow;
• Acceptable candidate for coronary artery bypass surgery (CABG);
• 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 Ethics Committee;
• Patient can be pretreated with aspirin and clopidogrel or, alternatively, aspirin alone plus a loading dose of 300 mg of clopidogrel before procedure completion in case of urgent PCI, and GPIIb IIIa inhibitors (Tirofiban or Abciximab)

You may not qualify if:

• Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK \>2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remains above normal at the time of treatment;
• Unprotected left main coronary disease with ≥50% stenosis;
• Significant (\>50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff;
• Have a target lesion in an arterial or venous by-pass graft;
• Calcified lesion which cannot be successfully predilated;
• Documented left ventricular ejection fraction ≤ 30%;
• TIMI 0-I coronary flow ;
• Impaired renal function (creatinine \> 3.0 mg/dl) at the time of treatment;
• Pretreatment with devices other than balloon angioplasty;
• Target lesion has excessive tortuousity or angulation (\>45°) which makes it unsuitable for stent delivery and deployment;
• Target lesion involves bifurcation including a diseased side branch ≥2 mm in diameter (either stenosis of both main vessel and major branch or stenosis of just major branch) that would require side branch stenting;
• Prior stent within 5mm of target lesion;
• Direct Stenting;
• Recipient of heart transplant;
• Patient with a life expectancy less than 12 months;

Sponsors & Collaborators

• Cordis US Corp.: lead

Study Sites (1)

Azienda USL Ravenna - Ospedale santa Maria delle Croci

Ravenna, 48100, Italy

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• A. Maresta, MD

  Azienda USL Ravenna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 4, 2007
• First Posted: July 6, 2007
• Study Start: January 1, 2004
• Primary Completion: March 1, 2006
• Study Completion: April 1, 2009
• Last Updated: February 4, 2010

Record last verified: 2010-02

Locations

IT (1)