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

This study has been terminated.
Sponsor:
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00489164
First received: June 20, 2007
Last updated: November 10, 2008
Last verified: November 2008
  Purpose

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.


Condition Intervention Phase
Peripheral Vascular Diseases
Device: Sirolimus-Eluting BX Velocity Balloon-Expandable Stent
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Randomized Feasibility Study With the Sirolimus-Eluting BX Velocity Balloon-Expandable Stent in the Treatment of Diabetic Patients With Native Coronary Artery Lesions (DECODE)

Resource links provided by NLM:


Further study details as provided by Cordis Corporation:

Primary Outcome Measures:
  • In-stent late lumen loss as measured by QCA at six months post-procedure. In-stent measurement is defined as the measurement within the stented segment. [ Time Frame: 6 months post-procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Composite of Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target lesion revascularization at 30 days, 6 months and 1 year post-procedure [ Time Frame: at 30 days, 6 months and 1 year post-procedure ] [ Designated as safety issue: Yes ]
  • Target lesion revascularization (TLR) and target vessel revascularization (TVR) at 30 days, 6 months and 1 year post-procedure [ Time Frame: at 30 days, 6 months and 1 year post-procedure ] [ Designated as safety issue: Yes ]
  • Target vessel failure (TVF) defined as cardiac death, myocardial infarction, or target vessel revascularization at 30 days, 6 months and 1 year post-procedure [ Time Frame: at 30 days, 6 months and 1 year post-procedure ] [ Designated as safety issue: Yes ]
  • Device success defined as achievement of a final residual diameter stenosis of <50% (by QCA), using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Lesion success defined as the attainment of <50% residual stenosis (by QCA) using any percutaneous method [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Procedure success defined as achievement of a final diameter stenosis of <50% (by QCA) using any percutaneous method, without the occurrence of death, MI, or repeat revascularization of the target lesion during the hospital stay [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  • In-stent mean percent diameter stenosis (%DS), Binary restenosis and late lumen loss as measured by quantitative coronary angiography at post-procedure and at 6-months [ Time Frame: at post-procedure and at 6-months ] [ Designated as safety issue: No ]
  • In-lesion mean percent diameter stenosis (%DS), mean lumen diameter (MLD), binary restenosis and late lumen loss as measured by quantitative coronary angiography at post-procedure and at 6-months [ Time Frame: at post-procedure and at 6-months ] [ Designated as safety issue: No ]
  • Glycemic control as measured by HbA1C at 6 months and 1 year follow-up [ Time Frame: at 6 months and 1 year follow-up ] [ Designated as safety issue: Yes ]

Enrollment: 83
Study Start Date: August 2002
Study Completion Date: May 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00489164

Locations
United States, California
Foundation for Cardiovascular Medicine
La Jolla, California, United States, 92037
United States, Florida
Florida Hospital
Orlando, Florida, United States, 32803
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Missouri
St Luke's Hospital
Kansas City, Missouri, United States, 64111
China
Queen Mary Hospital
Hong Kong, China
India
Batra Hospital & Research Centre
New Delhi, Delhi, India, 110062
Apollo Hospital
Chennai, Tamil Nadu, India, 600006
Jaslok Hospital & Research Centre
Mumbai, India, 400 026
Escorts Heart Institute & Research Centre
New Delhi, India, 110 025
Malaysia
National Heart Institute
Kuala Lumpur, Malaysia, 50400
Singapore
National Heart Center
Singapore, Singapore, 168752
Sponsors and Collaborators
Cordis Corporation
Investigators
Principal Investigator: Maurice Buchbinder, MD Scripps Memorial Hospital
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00489164     History of Changes
Other Study ID Numbers: P02-6316, P01-6311
Study First Received: June 20, 2007
Last Updated: November 10, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Cordis Corporation:
DIABETIC PATIENTS WITH NATIVE CORONARY ARTERY LESIONS

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Everolimus
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014