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Sponsored by: |
Vulnerable Plaque Society |
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Information provided by: | Vulnerable Plaque Society |
ClinicalTrials.gov Identifier: | NCT00798954 |
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.
Condition | Intervention | Phase |
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Ischemic Heart Disease Restenosis |
Device: Sirolimus-eluting coronary stent (Cypher) Device: Paclitaxel-eluting stent (TAXUS) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 800 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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TAXUS: Active Comparator |
Device: Paclitaxel-eluting stent (TAXUS)
Drug eluting stents: Comparison Sirolimus with Paclitaxel eluting stents for treatment of coronary bifurcation lesions.
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Cypher: Active Comparator |
Device: Sirolimus-eluting coronary stent (Cypher)
Drug eluting stents: Comparison Sirolimus with Paclitaxel eluting stents for treatment of coronary bifurcation lesions.
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Secondary Endpoints
2-1 Safety
1. Acute angiographic success
Minimum lumen diameter (MLD)
Minimum lumen diameter (MLD)
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patient Inclusion Criteria:
Angiographic Inclusion Criteria:
Exclusion Criteria:
Patient Exclusion Criteria:
Angiographic Exclusion Criteria:
Contact: Kenya Nasu, MD | 81-53-237-3377 | yuya0728@m3.kcn.ne.jp |
Japan, Aichi | |
Vulnerable Plaque Society | Recruiting |
Toyohashi, Aichi, Japan, 4400850 | |
Contact: Kenya Nasu, MD 81-53-237-3377 yuya0728@m3.kcn.ne.jp | |
Toyohashi Heart Center | Completed |
Toyohashi, Aichi, Japan, 4418530 | |
Higashi Cardiovascular Clinic | Completed |
Toyohashi, Aichi, Japan, 4400836 | |
Japan, Chiba | |
Teikyo University Chiba Medical Center | Completed |
Ichihara, Chiba, Japan, 2990111 | |
Japan, Fukushima | |
Southen Tohoku Research Institute | Completed |
Koriyama, Fukushima, Japan, 9638563 | |
Japan, Gunma | |
Gunma Cardiovascular Center | Completed |
Maebashi, Gunma, Japan, 3710004 | |
Japan, Hokkaido | |
Chitose City Hospital | Completed |
Chitose, Hokkaido, Japan, 0668550 | |
Hokkaido University Hospital | Completed |
Sapporo, Hokkaido, Japan, 0608648 | |
Kihara Junkanki Hospital | Completed |
Asahikawa, Hokkaido, Japan | |
Japan, Hyogo | |
Shinko Kagogwa Hospital | Completed |
Kakogawa, Hyogo, Japan, 6750115 | |
Sanda City Hospital | Completed |
Sanda, Hyogo, Japan, 6691321 | |
Japan, Osaka | |
Matsubara Tokushukai Hospital | Completed |
Matsubara, Osaka, Japan, 5800032 | |
Rinku General Medical Center | Completed |
Izumisano, Osaka, Japan, 5980048 | |
Japan, Tokyo | |
Itabashi Chuo Medical Center | Completed |
Itabashi, Tokyo, Japan, 1740051 | |
Tokyo Medical University Hospital | Completed |
Shinjuku, Tokyo, Japan, 1600023 | |
Tokyo Metropolitan Police Hospital | Completed |
Chiyoda, Tokyo, Japan, 1028161 | |
Japan, Tokyou | |
Cardiovascular Institute Hospital | Completed |
Minato-ku, Tokyou, Japan, 1060032 |
Principal Investigator: | Kenya Nasu, MD | Toyohashi Heart Center |
Principal Investigator: | Yuji Oikawa, MD | Cardiovascular Institute hospital |
Responsible Party: | Toyohashi Heart Center ( Kenya Nasu ) |
Study ID Numbers: | SKT |
Study First Received: | February 12, 2008 |
Last Updated: | July 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00798954 History of Changes |
Health Authority: | Japan: Institutional Review Board |
Sirolimus Anti-Infective Agents Heart Diseases Immunologic Factors Myocardial Ischemia Vascular Diseases Ischemia |
Antimitotic Agents Immunosuppressive Agents Anti-Bacterial Agents Paclitaxel Antifungal Agents Tubulin Modulators Antineoplastic Agents, Phytogenic |
Sirolimus Anti-Infective Agents Heart Diseases Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Myocardial Ischemia Mitosis Modulators Physiological Effects of Drugs Vascular Diseases Antimitotic Agents |
Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions Anti-Bacterial Agents Paclitaxel Therapeutic Uses Antifungal Agents Tubulin Modulators Cardiovascular Diseases Antineoplastic Agents, Phytogenic |