Intimal Hyperplasia Evaluated by Optical Coherence Tomography (OCT) in de Novo Coronary Lesions Treated by Drug-eluting Balloon and Bare-metal Stent (IN-PACT CORO)
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|ClinicalTrials.gov Identifier: NCT01057563|
Recruitment Status : Unknown
Verified January 2010 by Catholic University of the Sacred Heart.
Recruitment status was: Recruiting
First Posted : January 27, 2010
Last Update Posted : January 27, 2010
Restenosis due to neointimal hyperplasia causes repeat target vessel revascularization in a relevant number of patients undergoing percutaneous coronary interventions (PCI). Drug-eluting stents (DES) are currently adopted to reduce the rate of restenosis; however, they may increase risk of stent thrombosis.
Experimental data and first clinical experiences showed that inhibition of neointimal hyperplasia may be obtained by local administration of anti-proliferative drugs (like paclitaxel) loaded on the surface of angioplasty balloons. Data on the efficacy of novel coronary drug-eluting balloons (DEBs) are lacking.
Aims of this open label prospective, randomized trial is to evaluate neointimal hyperplasia in patients undergoing bare-metal stent (BMS) implantation alone compared to those receiving additional DEB use and to assess if the technique of DEB use may affect the degree of neointimal hyperplasia.
Neointimal hyperplasia will be assessed by Optical coherence tomography (OCT).
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Device: drug (paclitaxel)-eluting balloon (DEB) Device: bare-metal stent (BMS) Device: Drug (paclitaxel)-eluting balloon (DEB)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||IN-PACT CORO INtimal hyPerplasia evAluated by oCT in de Novo COROnary Lesions Treated by Drug-eluting Balloon and Bare-metal Stent|
|Study Start Date :||November 2009|
|Estimated Primary Completion Date :||November 2010|
Active Comparator: BMS group
Patients undergoing PCI with BMS implantation
Device: bare-metal stent (BMS)
Active Comparator: PRE-DEB group
Patients undergoing PCI with BMS implantation after lesion predilation with DEB
Device: drug (paclitaxel)-eluting balloon (DEB)
BMS implantation after lesion predilation with DEB
Active Comparator: POST-DEB group
Patients undergoing PCI with BMS implantation followed by postdilation with DEB
Device: Drug (paclitaxel)-eluting balloon (DEB)
BMS implantation followed by post-dilation with DEB
- Primary Endpoint: Neo-intimal area (mm²). [ Time Frame: 6 months post procedure ]
- Secondary Endpoints: - 6m percentage of uncovered struts. - 6m percentage of struts with ISA. - 6m percentage of protruding struts. [ Time Frame: 6 months post procedure ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01057563
|Contact: Francesco Burzotta, MD, PhDfirstname.lastname@example.org|
|Institute of Cardiology, Catholic University of Sacred Heart||Recruiting|
|Rome, Italy, 00168|
|Contact: Francesco Burzotta, MD, PhD 39-349-4295290 email@example.com|
|Principal Investigator:||Francesco Burzotta, MD, PhD||Catholic University of Sacred Heart|