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Sponsored by: |
Catholic University of the Sacred Heart |
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Information provided by: | Catholic University of the Sacred Heart |
ClinicalTrials.gov Identifier: | NCT00697372 |
BACKGROUND:
Bifurcated lesions are challenging target lesions in percutaneous coronary interventions (PCI) which may specifically benefit from the usage of drug-eluting stents (DES). However, the selection of the type of DES and the technique for DES implantation have not been clarified. In spite of the technique adopted, the side-branch (SB) is emerging as critical point, accounting for more than a third of the significant restenosis in the DES era. A series of data supports the adoption of a conservative strategy: stenting the main vessel (MV) only and reserving a conservative approach on the SB as this is not associated with worse outcome compared to more complex stenting strategies. Yet, the clinical relevance in terms of inducible ischemia of sub-optimal angiographic result has not been clarified.
AIMS OF THE STUDY:
The aims of the present study are:
METHODS TO BE APPLIED:
150 consecutive patients with bifurcated lesions undergoing PCI with the provisional TAP-stenting technique will be randomized to SES or EES implantation. Procedural details, post-PCI cardiac enzyme release, clinical outcome up to 1 year will be prospectively recorded. After the procedure, the subgroup of patients in which complete revascularization has been achieved (no untreated stenosis >50% in any other vessel, no residual stenosis >50% in any other treated vessel), will enter a systematic assessment of inducible ischemia by early (<8 days) and late (6-month) exercise tests.
Off line 3D QCA assessment will be performed and used to divide the study population in 2 groups according to the SB residual stenosis: Group O (optimal SB angiographic result): post-PCI SB area stenosis<50% and Group S (sub-optimal SB angiographic result): post-PCI SB area stenosis>50%.
PRIMARY STUDY END-POINTS.
Condition | Intervention | Phase |
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Coronary Artery Disease Coronary Stenosis Angioplasty, Transluminal, Percutaneous Coronary |
Device: Sirolimus eluting stent (Cypher stent - Cordis (Johnson&Johnson Company) Device: Everolimus eluting stent (Xience stent - Abbot company) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | SEA-SIDE: Sirolimus Versus Everolimus-Eluting Stent Randomized Assessment in Bifurcated Lesions and Clinical SIgnificance of Residual siDE-Branch Stenosis |
Estimated Enrollment: | 150 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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SES: Active Comparator
Patients with coronary bifurcation lesions treated by Sirolimus eluting stent
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Device: Sirolimus eluting stent (Cypher stent - Cordis (Johnson&Johnson Company)
Implantation of Sirolimus eluting stent
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EES: Active Comparator
Patients with coronary bifurcation lesions treated by Everolimus eluting stent
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Device: Everolimus eluting stent (Xience stent - Abbot company)
Implantation of Everolimus eluting stent
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Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Francesco Burzotta, MD, PhD | 39-34-9429-5290 | f.burzotta@rm.unicatt.it |
Italy | |
Institute of Cardiology - Catholic University of Sacred Heart | Recruiting |
Rome, Italy, 00168 | |
Contact: Francesco Burzotta, MD, PhD 39-34-9429-5290 f.burzotta@rm.unicatt.it | |
Principal Investigator: Francesco Burzotta, MD, PhD |
Responsible Party: | Catholic University of the Sacred Heart ( Francesco Burzotta MD PhD ) |
Study ID Numbers: | P648 |
Study First Received: | June 11, 2008 |
Last Updated: | June 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00697372 |
Health Authority: | Italy: Ethics Committee |
Drug-Eluting Stents |
Pathological Conditions, Anatomical Arterial Occlusive Diseases Sirolimus Everolimus Heart Diseases Clotrimazole Miconazole Myocardial Ischemia |
Tioconazole Vascular Diseases Constriction, Pathologic Ischemia Arteriosclerosis Coronary Stenosis Coronary Disease Coronary Artery Disease |
Anti-Bacterial Agents Anti-Infective Agents Immunologic Factors Antineoplastic Agents Antifungal Agents Therapeutic Uses |
Physiological Effects of Drugs Cardiovascular Diseases Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions |