Treatment of Bifurcation Lesions by SINGLE STENT and KISSing Balloon Trial

Phase 4

Completed

• Conditions: Ischemic Heart Disease; Restenosis

• Registration Number: NCT00798954
• Lead Sponsor: Vulnerable Plaque Society

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 where stenting the main branch could result in an obstruction of a vital side branch, many reports have been about using 2 drug-eluting stents. Resulting in less than favorable, target lesion revascularization (TLR) rates, with 10-15% for main branch and 11-40% for side branch.

In Japan, the PERFECT multi-center registry evaluated outcomes of single stenting plus kissing balloon technique after Directional Coronary Atherectomy (DCA) removal of tissue plaques. TLR rates for both main branch and side branch were a satisfactory 1.3%. However, the DCA technique is mainly suitable for proximal coronary artery lesions, and takes skilled operators.

For the treatment of relatively distal bifurcation lesions, where first POBA is performed, then the lesion is stented, followed by kissing balloon technique to fully expand the side branch, is considered a viable treatment. The Toyohashi Heart Center outcomes from August 2004 for this single stent and kissing ballooning technique, using the sirolimus-eluting stent on bifurcation lesions, achieved a satisfactory 5.2% TLR for both main and side branches, suggesting that using two stents may not be necessarily the ideal treatment.

The paclitaxel-eluting stent is expected to become available in Japan from June 2007. This stent's cells can be expanded to a maximum of 3.5mm, which should provide a larger lumen access for side-branch treatment.

As such, we developed this study to compare the outcomes of paclitaxel-eluting and sirolimus-eluting stents in bifurcation lesions that require side branch dilatation using the kissing ballooning technique.

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 associated with procedure (death, QMI, CABG)

2. Major complications at follow-up (within 9 months) (death, QMI, CABG)

3. Target vessel revascularization (TVR) performed within 9 months 2-2 Efficacy

1. Acute angiographic success

* Minimum lumen diameter (MLD)

・% stenosis 2. Angiographic success at follow-up

* Minimum lumen diameter (MLD)

・% stenosis

* Loss index

* Late loss

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2008-02-12
• Study First Submitted QC: 2008-11-26
• Study First Posted: 2008-11-27
• Primary Completion: 2008-12
• Study Completion: 2010-03
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-09
• Last Update Posted: 2010-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

Patient Inclusion Criteria:

1. Age ≥18 to <81 years and are able to undergo CABG
2. Females who are not pregnant
3. Patients who present with angina symptoms or myocardial ischemia
4. Patients available for post-procedural observation and coronary angiography at 9 months
5. Patients who have signed patient informed consent

Angiographic Inclusion Criteria:

1. Bifurcation lesion with ≥2.0mm side branch diameter as confirmed angiographically (the Duke Classification (see Reference 1)
2. The target lesion without remote lesions in the same vessel.
3. De novo lesion or non-stented restenosed lesion
4. Lesion which is eligible for stent implantation
5. Main branch reference vessel diameter of ≥2.5 mm by visual assessment
6. If two or more bifurcated lesions are present in the reference lesion, the proximal lesion shall be included in this study.

Exclusion Criteria

Patient Exclusion Criteria:

1. Patients contraindicated for antiplatelet therapy or anticoagulant therapy
2. Patients with significant allergic reaction to contrast medium
3. Patients who are pregnant or may be pregnant
4. Patients with left ventricle ejection fraction of <30%
5. Patients deemed inappropriate by physician

Angiographic Exclusion Criteria:

1. Main branch reference vessel diameter of ≥4.5 mm by angiography
2. Bypass grafts lesions
3. In-stent restenosis lesions
4. Highly tortuous lesions of ≥60 degrees
5. Highly calcified lesions in which full stent dilatation may not be possible
6. The target lesion with remote lesions in the same vessel.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Target lesion revascularization	one year

Trial Locations

Locations (17)

Higashi Cardiovascular Clinic; 🇯🇵 Toyohashi, Aichi, Japan

Vulnerable Plaque Society; 🇯🇵 Toyohashi, Aichi, Japan

Toyohashi Heart Center; 🇯🇵 Toyohashi, Aichi, Japan

Teikyo University Chiba Medical Center; 🇯🇵 Ichihara, Chiba, Japan

Southen Tohoku Research Institute; 🇯🇵 Koriyama, Fukushima, Japan

Gunma Cardiovascular Center; 🇯🇵 Maebashi, Gunma, Japan

Kihara Junkanki Hospital; 🇯🇵 Asahikawa, Hokkaido, Japan

Chitose City Hospital; 🇯🇵 Chitose, Hokkaido, Japan

Hokkaido University Hospital; 🇯🇵 Sapporo, Hokkaido, Japan

Shinko Kagogwa Hospital; 🇯🇵 Kakogawa, Hyogo, Japan

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