NCT00489164

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2002

Geographic Reach
5 countries

11 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 21, 2007

Completed
Last Updated

November 11, 2008

Status Verified

November 1, 2008

First QC Date

June 20, 2007

Last Update Submit

November 10, 2008

Conditions

Peripheral Vascular Diseases

Keywords

DIABETIC PATIENTS WITH NATIVE CORONARY ARTERY LESIONS

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months post-procedure

Secondary Outcomes (9)

  • 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

    at 30 days, 6 months and 1 year post-procedure

  • Target lesion revascularization (TLR) and target vessel revascularization (TVR) at 30 days, 6 months and 1 year post-procedure

    at 30 days, 6 months and 1 year post-procedure

  • Target vessel failure (TVF) defined as cardiac death, myocardial infarction, or target vessel revascularization at 30 days, 6 months and 1 year post-procedure

    at 30 days, 6 months and 1 year post-procedure

  • 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

    Throughout study

  • Lesion success defined as the attainment of <50% residual stenosis (by QCA) using any percutaneous method

    Throughout study

  • +4 more secondary outcomes

Interventions

Sirolimus-Eluting BX Velocity Balloon-Expandable StentDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient must be 18 years of age;
  • 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);
  • 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;
  • 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;
  • 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;
  • Target lesion is \>/=2.25 and \</=3.0 in diameter (visual estimate);
  • Individual lesions are \>/=10 mm to \</= 32 mm in length located in a native coronary artery;
  • Target lesions are de novo lesions in native coronary vessels;
  • Acceptable candidate for coronary artery bypass surgery (CABG);
  • Target lesion stenosis is \>50% and \<100% (TIMI I) (visual estimate);
  • 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.

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;
  • Patients admitted for treatment of diabetic ketoacidosis \>/= 2 times in the past six months (Brittle Diabetics);
  • Intervention of another lesion has occurred within six months prior to index procedure;
  • Have an ostial target lesion;
  • Target lesion is in a saphenous venous graft.
  • Target lesion is due to in-stent restenosis.
  • Angiographic evidence of thrombus within target lesion;
  • Calcified lesions which cannot be successfully predilated;
  • Ejection fraction \</=30%;
  • Totally occluded vessel (TIMI 0 level);
  • Impaired renal function (creatinine \> 2.0 mg/dL);
  • Target lesion has excessive tortuosity unsuitable for stent delivery and deployment;
  • Pretreatment with devices other than balloon angioplasty (direct stenting is not allowed);
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Foundation for Cardiovascular Medicine

La Jolla, California, 92037, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

St Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

Queen Mary Hospital

Hong Kong, China

Location

Batra Hospital & Research Centre

New Delhi, National Capital Territory of Delhi, 110062, India

Location

Apollo Hospital

Chennai, Tamil Nadu, 600006, India

Location

Jaslok Hospital & Research Centre

Mumbai, 400 026, India

Location

Escorts Heart Institute & Research Centre

New Delhi, 110 025, India

Location

National Heart Institute

Kuala Lumpur, 50400, Malaysia

Location

National Heart Center

Singapore, 168752, Singapore

Location

Related Publications (1)

  • Chan C, Zambahari R, Kaul U, Lau CP, Whitworth H, Cohen S, Buchbinder M; DECODE Investigators. A randomized comparison of sirolimus-eluting versus bare metal stents in the treatment of diabetic patients with native coronary artery lesions: the DECODE study. Catheter Cardiovasc Interv. 2008 Nov 1;72(5):591-600. doi: 10.1002/ccd.21719.

    PMID: 18949772RESULT

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Maurice Buchbinder, MD

    Scripps Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 20, 2007

First Posted

June 21, 2007

Study Start

August 1, 2002

Study Completion

May 1, 2004

Last Updated

November 11, 2008

Record last verified: 2008-11

Locations

CN(1)MY(1)US(4)IN(4)SG(1)