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)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Catholic University of the Sacred Heart.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT01057563
First received: January 26, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • Primary Endpoint: Neo-intimal area (mm²). [ Time Frame: 6 months post procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary Endpoints: - 6m percentage of uncovered struts. - 6m percentage of struts with ISA. - 6m percentage of protruding struts. [ Time Frame: 6 months post procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2009
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: BMS group
Patients undergoing PCI with BMS implantation
Device: bare-metal stent (BMS)
BMS implantation
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01057563

Contacts
Contact: Francesco Burzotta, MD, PhD 39-349-4295290 f.burzotta@rm.unicatt.it

Locations
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   
Sponsors and Collaborators
Catholic University of the Sacred Heart
Investigators
Principal Investigator: Francesco Burzotta, MD, PhD Catholic University of Sacred Heart
  More Information

Publications:
7. Tatsuya I, Mitsuyasu T, Yoshihiro T. Optical coherence tomography analysis of neointimal stent coverage in sirolimus eluting stents compared with bare metal stents. American College of Cardiology Scientific Sessions 2006. J Am Coll Cardiol 2006;47 Suppl:A2906-73

Additional 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
Study First Received: January 26, 2010
Last Updated: January 26, 2010
Health Authority: Italy: Ethics Committee

Keywords provided by Catholic University of the Sacred Heart:
Coronary artery disease
Neointimal hyperplasia
Drug-eluting balloon
Optical coherence tomography

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Hyperplasia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014