Completed

NCT Number: NCT00798954

Treatment of Bifurcation Lesions by SINGLE STENT and KISSing Balloon Trial

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.

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Key information

Conditions

Ischemic Heart Disease Cardiovascular Diseases Heart Diseases Myocardial Ischemia Restenosis Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Higashi Cardiovascular Clinic, Toyohashi, Aichi-ken, Japan

About this study

Primary Endpoints Target lesion revascularization after one year
Secondary Endpoints Secondary endpoints be evaluated in terms of safety and efficacy.

2-1 Safety

Major complications associated with procedure (death, QMI, CABG)
Major complications at follow-up (within 9 months) (death, QMI, CABG)
Target vessel revascularization (TVR) performed within 9 months 2-2 Efficacy

Acute angiographic success

Minimum lumen diameter (MLD)

・% stenosis 2. Angiographic success at follow-up

Minimum lumen diameter (MLD)

・% stenosis

Loss index
Late loss

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient Inclusion Criteria:

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

Angiographic Inclusion Criteria:

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.

Exclusion criteria

Patient Exclusion Criteria:

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

Angiographic Exclusion Criteria:

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.

Treatment and study plan

Sirolimus-eluting coronary stent (Cypher)

Device

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

Paclitaxel-eluting stent (TAXUS)

Device

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

Primary outcomes

Target lesion revascularization

Time frame: one year

Sponsors and collaborators

Lead sponsor

Vulnerable Plaque Society

Network

Registry information

Official study 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

Acronym: SINGLEKISS

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2010
First posted: Nov 27, 2008
Registry last updated: Jun 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed