Treatment of Bifurcation Lesions by SINGLE STENT and KISSing Balloon Trial

Ischemic Heart Disease Clinical Trial

— SINGLEKISS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00798954
• Other study ID #: SKT
• Status: Completed
• Phase: Phase 4
• First received: February 12, 2008
• Last updated: June 9, 2010
• Start date: June 2007
• Est. completion date: March 2010

Study information

• Verified date: June 2010
• Source: Vulnerable Plaque Society
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: March 2010
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Ischemic Heart Disease
• Myocardial Ischemia
• Restenosis

Intervention

Device:
• Sirolimus-eluting coronary stent (Cypher)
Drug eluting stents: Comparison Sirolimus with Paclitaxel eluting stents for treatment of coronary bifurcation lesions.
• Paclitaxel-eluting stent (TAXUS)
Drug eluting stents: Comparison Sirolimus with Paclitaxel eluting stents for treatment of coronary bifurcation lesions.

Locations

Country	Name	City	State
Japan	Kihara Junkanki Hospital	Asahikawa	Hokkaido
Japan	Chitose City Hospital	Chitose	Hokkaido
Japan	Tokyo Metropolitan Police Hospital	Chiyoda	Tokyo
Japan	Teikyo University Chiba Medical Center	Ichihara	Chiba
Japan	Itabashi Chuo Medical Center	Itabashi	Tokyo
Japan	Rinku General Medical Center	Izumisano	Osaka
Japan	Shinko Kagogwa Hospital	Kakogawa	Hyogo
Japan	Southen Tohoku Research Institute	Koriyama	Fukushima
Japan	Gunma Cardiovascular Center	Maebashi	Gunma
Japan	Matsubara Tokushukai Hospital	Matsubara	Osaka
Japan	Cardiovascular Institute Hospital	Minato-ku	Tokyou
Japan	Sanda City Hospital	Sanda	Hyogo
Japan	Hokkaido University Hospital	Sapporo	Hokkaido
Japan	Tokyo Medical University Hospital	Shinjuku	Tokyo
Japan	Higashi Cardiovascular Clinic	Toyohashi	Aichi
Japan	Toyohashi Heart Center	Toyohashi	Aichi
Japan	Vulnerable Plaque Society	Toyohashi	Aichi

Sponsors (1)

Lead Sponsor	Collaborator
Vulnerable Plaque Society

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target lesion revascularization		one year	Yes