Ischemic Heart Disease Clinical Trial
— SINGLEKISSOfficial 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
Verified date | June 2010 |
Source | Vulnerable Plaque Society |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Institutional Review Board |
Study type | Interventional |
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.
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Vulnerable Plaque Society |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Target lesion revascularization | one year | Yes |
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