Treatment of Bifurcation Lesions by SINGLE STENT and KISSing Balloon Trial

Last updated: June 9, 2010
Sponsor: Vulnerable Plaque Society
Overall Status: Completed

Phase

4

Condition

Myocardial Ischemia

Chest Pain

Hypercholesterolemia

Treatment

N/A

Clinical Study ID

NCT00798954
SKT
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 9months

  5. Patients who have signed patient informed consent Angiographic Inclusion Criteria:

  6. Bifurcation lesion with ≥2.0mm side branch diameter as confirmed angiographically (theDuke Classification (see Reference 1)

  7. The target lesion without remote lesions in the same vessel.

  8. De novo lesion or non-stented restenosed lesion

  9. Lesion which is eligible for stent implantation

  10. Main branch reference vessel diameter of ≥2.5 mm by visual assessment

  11. If two or more bifurcated lesions are present in the reference lesion, the proximallesion shall be included in this study.

Exclusion

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:

  6. Main branch reference vessel diameter of ≥4.5 mm by angiography

  7. Bypass grafts lesions

  8. In-stent restenosis lesions

  9. Highly tortuous lesions of ≥60 degrees

  10. Highly calcified lesions in which full stent dilatation may not be possible

  11. The target lesion with remote lesions in the same vessel.

Study Design

Total Participants: 800
Study Start date:
June 01, 2007
Estimated Completion Date:
March 31, 2010

Study 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

  4. Acute angiographic success

  • Minimum lumen diameter (MLD)

    ・% stenosis 2. Angiographic success at follow-up

  • Minimum lumen diameter (MLD)

    ・% stenosis

  • Loss index

  • Late loss

Connect with a study center

  • Higashi Cardiovascular Clinic

    Toyohashi, Aichi 4400836
    Japan

    Site Not Available

  • Toyohashi Heart Center

    Toyohashi, Aichi 4418530
    Japan

    Site Not Available

  • Vulnerable Plaque Society

    Toyohashi, Aichi 4400850
    Japan

    Site Not Available

  • Teikyo University Chiba Medical Center

    Ichihara, Chiba 2990111
    Japan

    Site Not Available

  • Southen Tohoku Research Institute

    Koriyama, Fukushima 9638563
    Japan

    Site Not Available

  • Gunma Cardiovascular Center

    Maebashi, Gunma 3710004
    Japan

    Site Not Available

  • Kihara Junkanki Hospital

    Asahikawa, Hokkaido
    Japan

    Site Not Available

  • Chitose City Hospital

    Chitose, Hokkaido 0668550
    Japan

    Site Not Available

  • Hokkaido University Hospital

    Sapporo, Hokkaido 0608648
    Japan

    Site Not Available

  • Shinko Kagogwa Hospital

    Kakogawa, Hyogo 6750115
    Japan

    Site Not Available

  • Sanda City Hospital

    Sanda, Hyogo 6691321
    Japan

    Site Not Available

  • Rinku General Medical Center

    Izumisano, Osaka 5980048
    Japan

    Site Not Available

  • Matsubara Tokushukai Hospital

    Matsubara, Osaka 5800032
    Japan

    Site Not Available

  • Tokyo Metropolitan Police Hospital

    Chiyoda, Tokyo 1028161
    Japan

    Site Not Available

  • Itabashi Chuo Medical Center

    Itabashi, Tokyo 1740051
    Japan

    Site Not Available

  • Tokyo Medical University Hospital

    Shinjuku, Tokyo 1600023
    Japan

    Site Not Available

  • Cardiovascular Institute Hospital

    Minato-ku, Tokyou 1060032
    Japan

    Site Not Available

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