Treatment of Bifurcation Lesions by SINGLE STENT and KISSing Balloon Trial (SINGLEKISS)

June 9, 2010 updated by: Vulnerable Plaque Society

A Multi-center Trial to Evaluate Paclitaxel- and Sirolimus-eluting Stents in Provisional T-stenting With Kissing Balloon Technique in the Treatment of Bifurcation Lesions

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

800

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Aichi
      • Toyohashi, Aichi, Japan, 4418530
        • Toyohashi Heart Center
      • Toyohashi, Aichi, Japan, 4400836
        • Higashi Cardiovascular clinic
      • Toyohashi, Aichi, Japan, 4400850
        • Vulnerable Plaque Society
    • Chiba
      • Ichihara, Chiba, Japan, 2990111
        • Teikyo University Chiba Medical Center
    • Fukushima
      • Koriyama, Fukushima, Japan, 9638563
        • Southen Tohoku Research Institute
    • Gunma
      • Maebashi, Gunma, Japan, 3710004
        • Gunma Cardiovascular Center
    • Hokkaido
      • Asahikawa, Hokkaido, Japan
        • Kihara Junkanki Hospital
      • Chitose, Hokkaido, Japan, 0668550
        • Chitose City Hospital
      • Sapporo, Hokkaido, Japan, 0608648
        • Hokkaido University Hospital
    • Hyogo
      • Kakogawa, Hyogo, Japan, 6750115
        • Shinko Kagogwa Hospital
      • Sanda, Hyogo, Japan, 6691321
        • Sanda City Hospital
    • Osaka
      • Izumisano, Osaka, Japan, 5980048
        • Rinku General Medical Center
      • Matsubara, Osaka, Japan, 5800032
        • Matsubara Tokushukai Hospital
    • Tokyo
      • Chiyoda, Tokyo, Japan, 1028161
        • Tokyo Metropolitan Police Hospital
      • Itabashi, Tokyo, Japan, 1740051
        • Itabashi Chuo Medical Center
      • Shinjuku, Tokyo, Japan, 1600023
        • Tokyo Medical University Hospital
    • Tokyou
      • Minato-ku, Tokyou, Japan, 1060032
        • Cardiovascular institute hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TAXUS
Device: Paclitaxel-eluting stent (TAXUS)
Drug eluting stents: Comparison Sirolimus with Paclitaxel eluting stents for treatment of coronary bifurcation lesions.
Active Comparator: Cypher
Device: Sirolimus-eluting coronary stent (Cypher)
Drug eluting stents: Comparison Sirolimus with Paclitaxel eluting stents for treatment of coronary bifurcation lesions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Target lesion revascularization
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vulnerable Plaque Society

Investigators

  • Principal Investigator: Yuji Oikawa, MD, Cardiovascular institute hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

February 12, 2008

First Submitted That Met QC Criteria

November 26, 2008

First Posted (Estimate)

November 27, 2008

Study Record Updates

Last Update Posted (Estimate)

June 10, 2010

Last Update Submitted That Met QC Criteria

June 9, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SKT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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