Status:
COMPLETED
Treatment of Bifurcation Lesions by SINGLE STENT and KISSing Balloon Trial
Lead Sponsor:
Vulnerable Plaque Society
Conditions:
Ischemic Heart Disease
Restenosis
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The use of DES have not diminished the need of improved treatment strategies , especially the treatment of bifurcation lesions still leave much to be clarified. Particularly, for bifurcation lesions w...
Detailed Description
1. Primary Endpoints Target lesion revascularization after one year 2. Secondary Endpoints Secondary endpoints be evaluated in terms of safety and efficacy. 2-1 Safety 1. Major complications associa...
Eligibility Criteria
Inclusion
- Patient
- Age ≥18 to \<81 years and are able to undergo CABG
- Females who are not pregnant
- Patients who present with angina symptoms or myocardial ischemia
- Patients available for post-procedural observation and coronary angiography at 9 months
- Patients who have signed patient informed consent
- Angiographic
- Bifurcation lesion with ≥2.0mm side branch diameter as confirmed angiographically (the Duke Classification (see Reference 1)
- The target lesion without remote lesions in the same vessel.
- De novo lesion or non-stented restenosed lesion
- Lesion which is eligible for stent implantation
- Main branch reference vessel diameter of ≥2.5 mm by visual assessment
- If two or more bifurcated lesions are present in the reference lesion, the proximal lesion shall be included in this study.
Exclusion
- Patient
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2010
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT00798954
Start Date
June 1 2007
End Date
March 1 2010
Last Update
June 10 2010
Active Locations (17)
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1
Higashi Cardiovascular Clinic
Toyohashi, Aichi-ken, Japan, 4400836
2
Vulnerable Plaque Society
Toyohashi, Aichi-ken, Japan, 4400850
3
Toyohashi Heart Center
Toyohashi, Aichi-ken, Japan, 4418530
4
Teikyo University Chiba Medical Center
Ichihara, Chiba, Japan, 2990111