Treatment of Bifurcation Lesions by SINGLE STENT and KISSing Balloon Trial

NCT ID: NCT00798954

Last Updated: 2010-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2010-03-31

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

Conditions

Ischemic Heart Disease; Restenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

TAXUS

Group Type: ACTIVE_COMPARATOR

Paclitaxel-eluting stent (TAXUS)

Intervention Type: DEVICE

Drug eluting stents: Comparison Sirolimus with Paclitaxel eluting stents for treatment of coronary bifurcation lesions.

Cypher

Group Type: ACTIVE_COMPARATOR

Sirolimus-eluting coronary stent (Cypher)

Intervention Type: DEVICE

Drug eluting stents: Comparison Sirolimus with Paclitaxel eluting stents for treatment of coronary bifurcation lesions.

Interventions

Sirolimus-eluting coronary stent (Cypher)

Drug eluting stents: Comparison Sirolimus with Paclitaxel eluting stents for treatment of coronary bifurcation lesions.

Intervention Type: DEVICE

Paclitaxel-eluting stent (TAXUS)

Drug eluting stents: Comparison Sirolimus with Paclitaxel eluting stents for treatment of coronary bifurcation lesions.

Intervention Type: DEVICE

Eligibility Criteria

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

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

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vulnerable Plaque Society

NETWORK

Sponsor Role: lead

Responsible Party

Toyohashi Heart Center

Principal Investigators

Kenya Nasu, MD

Role: PRINCIPAL_INVESTIGATOR

Toyohashi Heart Center

Yuji Oikawa, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiovascular Institute hospital

Locations

Higashi Cardiovascular Clinic

Toyohashi, Aichi-ken, Japan

Vulnerable Plaque Society

Toyohashi, Aichi-ken, Japan

Toyohashi Heart Center

Toyohashi, Aichi-ken, Japan

Teikyo University Chiba Medical Center

Ichihara, Chiba, Japan

Southen Tohoku Research Institute

Kōriyama, 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, Hyōgo, Japan

Sanda City Hospital

Sanda, Hyōgo, Japan

Rinku General Medical Center

Izumisano, Osaka, Japan

Matsubara Tokushukai Hospital

Matsubara, Osaka, Japan

Tokyo Metropolitan Police Hospital

Chiyoda City, Tokyo, Japan

Tokyo Medical University Hospital

Shinjuku, Tokyo, Japan

Itabashi Chuo Medical Center

tabashi City, Tokyo, Japan

Cardiovascular Institute Hospital

Minatoku, Tokyou, Japan

Countries

Japan

Other Identifiers

SKT

Identifier Type: -

Identifier Source: org_study_id