Feasibility Study With the Sirolimus-Eluting BX Velocity Balloon-Expandable Stent in the Treatment of Diabetic Patients With Native Coronary Artery Lesions (DECODE)

Cordis

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Peripheral Vascular Diseases

Treatments: Device: Sirolimus-Eluting BX Velocity Balloon-Expandable Stent

Study type: Interventional

Funder types: Industry

Identifiers

NCT00489164

P02-6316, P01-6311

Details and patient eligibility

About

The main objective of this study is to assess in-stent late lumen loss in diabetic patients with de novo native coronary lesions using the sirolimus-eluting Bx VELOCITYä stent as compared to the Bx VELOCITY balloon-expandable stent.

Enrollment: 83 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The patient must be 18 years of age;
2. Patients must be previously diagnosed with Type I or Type II diabetes with documented treatment with insulin or oral hypoglycemics by medical history. (Undocumented or newly diagnosed diabetics must have fasting plasma glucose of >/= 126 mg/dl or a 2h post-load value in the OGTT >/=200 mg/dl, confirmed on alternate days);
3. Female of childbearing potential must have a negative pregnancy test and must plan to be on accepted method of contraception for 6 months after time of enrollment;
4. 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;
5. Treatment of lesions in native coronary arteries requiring a maximum of three stents per patient. Multi-vessel treatment is permissible. Additional stents may be used for procedural complications such as dissections. Patients with additional lesions can be included only if the other lesions are not considered clinically significant and do not require treatment;
6. Target lesion is >/=2.25 and </=3.0 in diameter (visual estimate);
7. Individual lesions are >/=10 mm to </= 32 mm in length located in a native coronary artery;
8. Target lesions are de novo lesions in native coronary vessels;
9. Acceptable candidate for coronary artery bypass surgery (CABG);
10. Target lesion stenosis is >50% and <100% (TIMI I) (visual estimate);
11. Patient is willing to comply with the specified follow-up evaluation;
12. Patient must provide written informed consent prior to the procedure using a form that is approved by the local Institutional Review Board.

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. Unprotected left main coronary disease with 50% stenosis;
3. Significant (>/=50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff;
4. Patients admitted for treatment of diabetic ketoacidosis >/= 2 times in the past six months (Brittle Diabetics);
5. Intervention of another lesion has occurred within six months prior to index procedure;
6. Have an ostial target lesion;
7. Target lesion is in a saphenous venous graft.
8. Target lesion is due to in-stent restenosis.
9. Angiographic evidence of thrombus within target lesion;
10. Calcified lesions which cannot be successfully predilated;
11. Ejection fraction </=30%;
12. Totally occluded vessel (TIMI 0 level);
13. Impaired renal function (creatinine > 2.0 mg/dL);
14. Target lesion has excessive tortuosity unsuitable for stent delivery and deployment;
15. Pretreatment with devices other than balloon angioplasty (direct stenting is not allowed);
16. Target lesion involves bifurcation including a side branch >/=2.5mm 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;
17. Previous brachytherapy of target vessel;
18. Recipient of heart transplant;
19. Patient with a life expectancy less than 12 months;
20. Known allergies to aspirin, clopidogrel bisulfate (Plavix) and ticlopidine (Ticlid), heparin, stainless steel, contrast agent or sirolimus, that cannot be medically managed;
21. Any significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study;
22. Currently participating in an investigational drug or another device study;
23. Treatment with Metformin (glucophage) within 48 hours of angiogram.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind