ClinicalTrials.Veeva

Menu

Double or Single Dose Sirolimus-Eluting Stents in Diabetic Patients With de Novo Coronary Artery Lesions (3D)

C

Cordis

Status and phase

Completed
Phase 2
Phase 1

Conditions

Coronary Artery Disease

Treatments

Device: CYPHER Sirolimus-Eluting Coronary Stent

Study type

Interventional

Funder types

Industry

Identifiers

NCT00233714
P03-6318

Details and patient eligibility

About

The main objective of this study is to assess safety and effectiveness of double dose sirolimus-eluting Bx VELOCITY stents in diabetic patients with a de novo native coronary lesion, as compared to single dose sirolimus-eluting Bx VELOCITY™ stents.

Enrollment

56 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. The patient must be minimum 18 years of age;
  2. Patients must be previously diagnosed with diabetes with documented treatment with insulin, oral medications, or diet for a minimum of 3 months;
  3. 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-III) OR patients with documented silent ischemia;
  4. Treatment of one lesion in a native coronary artery. The treated lesion will be the one with the highest % diameter stenosis by visual estimate. Additional study stents may be used for procedural complications such as dissections. Multivessel treatment is permissible in non-target vessels; however, additional lesions may only be treated with commercial stents. If other non-target lesions are treated with commercial stents during the index procedure, they must be successfully treated prior to the study lesion;
  5. The target vessel is 2.5 mm and 3.5mm in diameter (visual estimate);
  6. The target lesion is <30 mm in length (visual estimate) located in a native coronary artery;
  7. Target lesion stenosis is >50% and <100% (TIMI I) (visual estimate);

Exclusion criteria

  1. 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;
  2. Patients admitted for treatment of diabetic ketoacidosis > 2 times in the past six months (Brittle Diabetics);
  3. Ejection fraction 30%;
  4. Impaired renal function (creatinine > 2.0 mg/dL);

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

56 participants in 2 patient groups

1
Active Comparator group
Description:
Single-dose Sirolimus-Eluting Coronary stent
Treatment:
Device: CYPHER Sirolimus-Eluting Coronary Stent
Device: CYPHER Sirolimus-Eluting Coronary Stent
2
Active Comparator group
Description:
Double-dose Sirolimus-Eluting Coronary stent
Treatment:
Device: CYPHER Sirolimus-Eluting Coronary Stent
Device: CYPHER Sirolimus-Eluting Coronary Stent

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems