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A Multi-center, Open label, Randomized Controlled Efficacy study of Direct stenting compared to Conventional stenting in Diabetic patients undergoing Elective angioplasty for Coronary Artery Disease

A Multi-center, Open label, Randomized Controlled Efficacy study of Direct stenting compared to Conventional stenting in Diabetic patients undergoing Elective angioplasty for Coronary Artery Disease

DECIDE Trial

General Information
Research Type
Interventional
Description
This is a multi-center, open label parallel group randomized controlled trial designed to evaluate the efficacy of direct stenting compared to conventional stenting.
164 patients with Coronary artery disease from 3 participating sites who meet inclusion/exclusion criteria will be enrolled into the trial.
After initial screening, patients will attend clinic for baseline examination. Subjects will then be randomly allocated to direct stenting or conventional stenting in a ratio of 1:1.
Study visits will occur at 1-month and 3-month post intervention for efficacy assessments. Final study visit will occur at 6-month post intervention and Quantitative Coronary Angiography will be performed
Study Information
RMK Priority Area
Research Level
Research Keyword
coronary artery disease, angioplasty, stenting, diabetes
Inclusion & Exclusion Criteria
Inclusion Criteria
Inclusion criteria:
1. Written informed consent obtained from patient or parents/guardian.
2. Subject age >= 21 and <=80 years
3. Diabetic patients undergoing elective percutaneous coronary intervention involving the planned use of stent
4. De novo native coronary obstructive lesions > 50% diameter stenosis whether of single or multivessel.
5. De novo native coronary obstructive lesions of <20mm whether of single or multivessel.
6. Vessel diameter between 2.5mm and 4.0mm whether of single or multivessel.

Exclusion criteria:
1. Participation in any trial in which the patient had stenting.
2. Lesions deemed to be unsuitable for direct coronary stenting (moderately or severely calcified stenoses, proximal marked tortuosity, long stenosis, chronic total occlusion)
3. In-stent restenotic lesion
4. Those persons directly involved in the conduct of the study.
5. Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of this study or render patient unfit for the procedure.
Exclusion Criteria
Inclusion criteria:
1. Written informed consent obtained from patient or parents/guardian.
2. Subject age >= 21 and <=80 years
3. Diabetic patients undergoing elective percutaneous coronary intervention involving the planned use of stent
4. De novo native coronary obstructive lesions > 50% diameter stenosis whether of single or multivessel.
5. De novo native coronary obstructive lesions of <20mm whether of single or multivessel.
6. Vessel diameter between 2.5mm and 4.0mm whether of single or multivessel.

Exclusion criteria:
1. Participation in any trial in which the patient had stenting.
2. Lesions deemed to be unsuitable for direct coronary stenting (moderately or severely calcified stenoses, proximal marked tortuosity, long stenosis, chronic total occlusion)
3. In-stent restenotic lesion
4. Those persons directly involved in the conduct of the study.
5. Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of this study or render patient unfit for the procedure.
Study Timeline
Expected / Actual Date Study Starts - First Enrolment of subject / Collecting data
Jul, 01 2001
Expected / Actual Date Study Completed
Oct, 28 2003
Expected / Actual Duration of Study Enrollment / Data Collection
121 weeks