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Treatment of Bifurcation Lesions by SINGLE STENT and KISSing Balloon Trial (SINGLEKISS)
This study is currently recruiting participants.
Verified by Vulnerable Plaque Society, July 2009
First Received: February 12, 2008   Last Updated: July 28, 2009   History of Changes
Sponsored by: Vulnerable Plaque Society
Information provided by: Vulnerable Plaque Society
ClinicalTrials.gov Identifier: NCT00798954
  Purpose

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.


Condition Intervention Phase
Ischemic Heart Disease
Restenosis
Device: Sirolimus-eluting coronary stent (Cypher)
Device: Paclitaxel-eluting stent (TAXUS)
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Vulnerable Plaque Society:

Primary Outcome Measures:
  • angiographically binary restenosis [ Time Frame: 9 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 800
Study Start Date: June 2007
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
TAXUS: Active Comparator Device: Paclitaxel-eluting stent (TAXUS)
Drug eluting stents: Comparison Sirolimus with Paclitaxel eluting stents for treatment of coronary bifurcation lesions.
Cypher: Active Comparator Device: Sirolimus-eluting coronary stent (Cypher)
Drug eluting stents: Comparison Sirolimus with Paclitaxel eluting stents for treatment of coronary bifurcation lesions.

Detailed Description:
  1. Primary Endpoints Major endpoints of this study are angiographically binary restenosis (defined as ≥50% restenosis by QCA) in the target lesion and target lesion revascularization (TLR) at 9 month (+1 month) follow-up.
  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
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00798954

Contacts
Contact: Kenya Nasu, MD 81-53-237-3377 yuya0728@m3.kcn.ne.jp

Locations
Japan, Aichi
Vulnerable Plaque Society Recruiting
Toyohashi, Aichi, Japan, 4400850
Contact: Kenya Nasu, MD     81-53-237-3377     yuya0728@m3.kcn.ne.jp    
Toyohashi Heart Center Completed
Toyohashi, Aichi, Japan, 4418530
Higashi Cardiovascular Clinic Completed
Toyohashi, Aichi, Japan, 4400836
Japan, Chiba
Teikyo University Chiba Medical Center Completed
Ichihara, Chiba, Japan, 2990111
Japan, Fukushima
Southen Tohoku Research Institute Completed
Koriyama, Fukushima, Japan, 9638563
Japan, Gunma
Gunma Cardiovascular Center Completed
Maebashi, Gunma, Japan, 3710004
Japan, Hokkaido
Chitose City Hospital Completed
Chitose, Hokkaido, Japan, 0668550
Hokkaido University Hospital Completed
Sapporo, Hokkaido, Japan, 0608648
Kihara Junkanki Hospital Completed
Asahikawa, Hokkaido, Japan
Japan, Hyogo
Shinko Kagogwa Hospital Completed
Kakogawa, Hyogo, Japan, 6750115
Sanda City Hospital Completed
Sanda, Hyogo, Japan, 6691321
Japan, Osaka
Matsubara Tokushukai Hospital Completed
Matsubara, Osaka, Japan, 5800032
Rinku General Medical Center Completed
Izumisano, Osaka, Japan, 5980048
Japan, Tokyo
Itabashi Chuo Medical Center Completed
Itabashi, Tokyo, Japan, 1740051
Tokyo Medical University Hospital Completed
Shinjuku, Tokyo, Japan, 1600023
Tokyo Metropolitan Police Hospital Completed
Chiyoda, Tokyo, Japan, 1028161
Japan, Tokyou
Cardiovascular Institute Hospital Completed
Minato-ku, Tokyou, Japan, 1060032
Sponsors and Collaborators
Vulnerable Plaque Society
Investigators
Principal Investigator: Kenya Nasu, MD Toyohashi Heart Center
Principal Investigator: Yuji Oikawa, MD Cardiovascular Institute hospital
  More Information

No publications provided

Responsible Party: Toyohashi Heart Center ( Kenya Nasu )
Study ID Numbers: SKT
Study First Received: February 12, 2008
Last Updated: July 28, 2009
ClinicalTrials.gov Identifier: NCT00798954     History of Changes
Health Authority: Japan: Institutional Review Board

Study placed in the following topic categories:
Sirolimus
Anti-Infective Agents
Heart Diseases
Immunologic Factors
Myocardial Ischemia
Vascular Diseases
Ischemia
Antimitotic Agents
Immunosuppressive Agents
Anti-Bacterial Agents
Paclitaxel
Antifungal Agents
Tubulin Modulators
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:
Sirolimus
Anti-Infective Agents
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Myocardial Ischemia
Mitosis Modulators
Physiological Effects of Drugs
Vascular Diseases
Antimitotic Agents
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions
Anti-Bacterial Agents
Paclitaxel
Therapeutic Uses
Antifungal Agents
Tubulin Modulators
Cardiovascular Diseases
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on September 10, 2009