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
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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 |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Arm | Intervention/treatment |
---|---|
Active Comparator: BMS group
Patients undergoing PCI with BMS implantation
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Device: bare-metal stent (BMS)
BMS implantation |
Active Comparator: PRE-DEB group
Patients undergoing PCI with BMS implantation after lesion predilation with DEB
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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
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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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both (female sex with child-bearing potential excluded) Accepts Healthy Volunteers: No
Inclusion Criteria:
- Non-diabetic patients with a stable coronary artery disease, undergoing elective PCI with BMS
- de novo non-complex lesions (no bifurcation lesions, no chronic total occlusions, no severe calcifications, no moderate-to-severe tortuosities) located in straight coronary segments.
- lesion length ≥10 mm and <25 mm.
- vessel size requiring a single stent with diameter between 3.0 and 3.5mm.
Exclusion Criteria:
Clinical:
- age <18 years or impossibility to give informed consent,
- diabetes mellitus
- female sex with child-bearing potential,
- life expectancy less than 6 months or any condition impeding clinical follow-up (no fixed address, etc),
- significant platelet count alteration (<100,000 cells/mm3 or > 700,000 cells/mm3),
- gastrointestinal bleeding requiring surgery or blood transfusions within 4 previous weeks,
- participation to another study with any investigational device or drug within which is still in the active phase.
- history of clotting pathology, known hypersensitivity to aspirin, heparin, cobalt- chromium, paclitaxel, contrast dye,
- renal failure with creatinine value > 2.5 mg/dl,
- poor cardiac function as defined by left ventricular global ejection fraction ≤ 30%
- acute myocardial infarction within the past 48 hours.
- non ST-elevation acute coronary syndrome
Angiographic:
- left main coronary artery disease,
- lesions in coronary artery bypass grafts,
- no suitable anatomy for OCT scan
- bifurcation lesions, chronic total occlusions, severe calcifications, moderate-to-severe tortuosities
- presence of additional non target lesions requiring treatment, within and outside the target vessel, which are not successfully treated (non target lesions must be treated prior to the target lesion)

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, PhD | 39-349-4295290 | f.burzotta@rm.unicatt.it |
Italy | |
Institute of Cardiology, Catholic University of Sacred Heart | Recruiting |
Rome, Italy, 00168 | |
Contact: Francesco Burzotta, MD, PhD 39-349-4295290 f.burzotta@rm.unicatt.it |
Principal Investigator: | Francesco Burzotta, MD, PhD | Catholic University of Sacred Heart |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Francesco Burzotta, MD, PhD, Catholic University of Sacred Heart |
ClinicalTrials.gov Identifier: | NCT01057563 History of Changes |
Other Study ID Numbers: |
A/582/CE/2009 |
First Posted: | January 27, 2010 Key Record Dates |
Last Update Posted: | January 27, 2010 |
Last Verified: | January 2010 |
Coronary artery disease Neointimal hyperplasia Drug-eluting balloon Optical coherence tomography |
Coronary Artery Disease Myocardial Ischemia Coronary Disease Hyperplasia Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
Pathologic Processes Paclitaxel Albumin-Bound Paclitaxel Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |