Treatment of Bifurcation Lesions by SINGLE STENT and KISSing Balloon Trial

NCT00798954 | Completed Phase 4 DMC

• 1 other identifier: SKT
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 17

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.

Conditions

Ischemic Heart Disease; Restenosis

Outcome Measures

Primary Outcomes (1)

• Target lesion revascularization

  one year

Study Arms (2)

TAXUS

ACTIVE COMPARATOR

Device: Paclitaxel-eluting stent (TAXUS)

Cypher

ACTIVE COMPARATOR

Device: Sirolimus-eluting coronary stent (Cypher)

Interventions

Sirolimus-eluting coronary stent (Cypher) DEVICE

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

Cypher

Paclitaxel-eluting stent (TAXUS) DEVICE

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

TAXUS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 to \<81 years and are able to undergo CABG
• Females who are not pregnant
• Patients who present with angina symptoms or myocardial ischemia
• Patients available for post-procedural observation and coronary angiography at 9 months
• Patients who have signed patient informed consent
• Bifurcation lesion with ≥2.0mm side branch diameter as confirmed angiographically (the Duke Classification (see Reference 1)
• The target lesion without remote lesions in the same vessel.
• De novo lesion or non-stented restenosed lesion
• Lesion which is eligible for stent implantation
• Main branch reference vessel diameter of ≥2.5 mm by visual assessment
• If two or more bifurcated lesions are present in the reference lesion, the proximal lesion shall be included in this study.

You may not qualify if:

• Patients contraindicated for antiplatelet therapy or anticoagulant therapy
• Patients with significant allergic reaction to contrast medium
• Patients who are pregnant or may be pregnant
• Patients with left ventricle ejection fraction of \<30%
• Patients deemed inappropriate by physician
• Main branch reference vessel diameter of ≥4.5 mm by angiography
• Bypass grafts lesions
• In-stent restenosis lesions
• Highly tortuous lesions of ≥60 degrees
• Highly calcified lesions in which full stent dilatation may not be possible
• The target lesion with remote lesions in the same vessel.

Sponsors & Collaborators

• Vulnerable Plaque Society: lead

Study Sites (17)

Higashi Cardiovascular Clinic

Toyohashi, Aichi-ken, 4400836, Japan

Location

Vulnerable Plaque Society

Toyohashi, Aichi-ken, 4400850, Japan

Location

Toyohashi Heart Center

Toyohashi, Aichi-ken, 4418530, Japan

Location

Teikyo University Chiba Medical Center

Ichihara, Chiba, 2990111, Japan

Location

Southen Tohoku Research Institute

Kōriyama, Fukushima, 9638563, Japan

Location

Gunma Cardiovascular Center

Maebashi, Gunma, 3710004, Japan

Location

Kihara Junkanki Hospital

Asahikawa, Hokkaido, Japan

Location

Chitose City Hospital

Chitose, Hokkaido, 0668550, Japan

Location

Hokkaido University Hospital

Sapporo, Hokkaido, 0608648, Japan

Location

Shinko Kagogwa Hospital

Kakogawa, Hyōgo, 6750115, Japan

Location

Sanda City Hospital

Sanda, Hyōgo, 6691321, Japan

Location

Rinku General Medical Center

Izumisano, Osaka, 5980048, Japan

Location

Matsubara Tokushukai Hospital

Matsubara, Osaka, 5800032, Japan

Location

Tokyo Metropolitan Police Hospital

Chiyoda City, Tokyo, 1028161, Japan

Location

Tokyo Medical University Hospital

Shinjuku, Tokyo, 1600023, Japan

Location

Itabashi Chuo Medical Center

tabashi City, Tokyo, 1740051, Japan

Location

Cardiovascular Institute Hospital

Minatoku, Tokyou, 1060032, Japan

Location

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Kenya Nasu, MD

  Toyohashi Heart Center

  PRINCIPAL INVESTIGATOR

• Yuji Oikawa, MD

  Cardiovascular Institute hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: February 12, 2008
• First Posted: November 27, 2008
• Study Start: June 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: March 1, 2010
• Last Updated: June 10, 2010

Record last verified: 2010-06

Locations

JP (17)