Clinical trial NCT00798954: Treatment of Bifurcation Lesions by SINGLE STENT and KISSing Balloon Trial
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ischemic Heart Disease
Restenosis
Lead sponsor: Vulnerable Plaque Society
Sponsor class: NETWORK
First posted: 2008-11-27
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility 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.

Primary outcomes:
measure: Target lesion revascularization
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Toyohashi
country: Japan
facility: Higashi Cardiovascular Clinic
state: Aichi
city: Toyohashi
country: Japan
facility: Vulnerable Plaque Society
state: Aichi
city: Toyohashi
country: Japan
facility: Toyohashi Heart Center
state: Aichi
city: Ichihara
country: Japan
facility: Teikyo University Chiba Medical Center
state: Chiba
city: Koriyama
country: Japan
facility: Southen Tohoku Research Institute
state: Fukushima
city: Maebashi
country: Japan
facility: Gunma Cardiovascular Center
state: Gunma
city: Asahikawa
country: Japan
facility: Kihara Junkanki Hospital
state: Hokkaido
city: Chitose
country: Japan
facility: Chitose City Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Kakogawa
country: Japan
facility: Shinko Kagogwa Hospital
state: Hyogo
city: Sanda
country: Japan
facility: Sanda City Hospital
state: Hyogo
city: Izumisano
country: Japan
facility: Rinku General Medical Center
state: Osaka
city: Matsubara
country: Japan
facility: Matsubara Tokushukai Hospital
state: Osaka
city: Minato-ku
country: Japan
facility: Cardiovascular Institute Hospital
state: Tokyou
city: Chiyoda
country: Japan
facility: Tokyo Metropolitan Police Hospital
state: Tokyo
city: Itabashi
country: Japan
facility: Itabashi Chuo Medical Center
state: Tokyo
city: Shinjuku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
Study officials:
affiliation: Toyohashi Heart Center
name: Kenya Nasu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiovascular Institute hospital
name: Yuji Oikawa, MD
role: PRINCIPAL_INVESTIGATOR
References: