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)

• ClinicalTrials.gov Identifier: NCT01057563
• Recruitment Status: Unknown
• First Posted: January 27, 2010
• Last Update Posted: January 27, 2010
• Sponsor: Catholic University of the Sacred Heart
• Information provided by: Catholic University of the Sacred Heart

Study Description

Brief Summary:

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

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Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Primary Endpoint: Neo-intimal area (mm²). [ Time Frame: 6 months post procedure ]

Secondary Outcome Measures :

1. Secondary Endpoints: - 6m percentage of uncovered struts. - 6m percentage of struts with ISA. - 6m percentage of protruding struts. [ Time Frame: 6 months post procedure ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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:

Waugh J, Wagstaff AJ. The paclitaxel (TAXUS)-eluting stent: a review of its use in the management of de novo coronary artery lesions. Am J Cardiovasc Drugs. 2004;4(4):257-68. Review.

Unverdorben M, Vallbracht C, Cremers B, Heuer H, Hengstenberg C, Maikowski C, Werner GS, Antoni D, Kleber FX, Bocksch W, Leschke M, Ackermann H, Boxberger M, Speck U, Degenhardt R, Scheller B. Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis. Circulation. 2009 Jun 16;119(23):2986-94. doi: 10.1161/CIRCULATIONAHA.108.839282. Epub 2009 Jun 1.

Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Böhm M, Speck U. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med. 2006 Nov 16;355(20):2113-24. Epub 2006 Nov 13.

Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Böhm M, Speck U. Two year follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. Clin Res Cardiol. 2008 Oct;97(10):773-81. doi: 10.1007/s00392-008-0682-5. Epub 2008 Jun 5.

Prati F, Cera M, Ramazzotti V, Imola F, Giudice R, Albertucci M. Safety and feasibility of a new non-occlusive technique for facilitated intracoronary optical coherence tomography (OCT) acquisition in various clinical and anatomical scenarios. EuroIntervention. 2007 Nov;3(3):365-70.

Chen BX, Ma FY, Luo W, Ruan JH, Xie WL, Zhao XZ, Sun SH, Guo XM, Wang F, Tian T, Chu XW. Neointimal coverage of bare-metal and sirolimus-eluting stents evaluated with optical coherence tomography. Heart. 2008 May;94(5):566-70.

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

Moore P, Barlis P, Spiro J, Ghimire G, Roughton M, Di Mario C, Wallis W, Ilsley C, Mitchell A, Mason M, Kharbanda R, Vincent P, Sherwin S, Dalby M. A randomized optical coherence tomography study of coronary stent strut coverage and luminal protrusion with rapamycin-eluting stents. JACC Cardiovasc Interv. 2009 May;2(5):437-44. doi: 10.1016/j.jcin.2009.01.010.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Burzotta F, Brancati MF, Trani C, Pirozzolo G, De Maria G, Leone AM, Niccoli G, Porto I, Prati F, Crea F. Impact of drug-eluting balloon (pre- or post-) dilation on neointima formation in de novo lesions treated by bare-metal stent: the IN-PACT CORO trial. Heart Vessels. 2016 May;31(5):677-86. doi: 10.1007/s00380-015-0671-3. Epub 2015 Apr 12.

De Maria GL, Porto I, Burzotta F, Brancati MF, Trani C, Pirozzolo G, Leone AM, Niccoli G, Prati F, Crea F. Dual role of circulating endothelial progenitor cells in stent struts endothelialisation and neointimal regrowth: a substudy of the IN-PACT CORO trial. Cardiovasc Revasc Med. 2015 Jan-Feb;16(1):20-6. doi: 10.1016/j.carrev.2014.10.008. Epub 2014 Oct 31.

Burzotta F, Brancati MF, Trani C, Porto I, Tommasino A, De Maria G, Niccoli G, Leone AM, Coluccia V, Schiavoni G, Crea F. INtimal hyPerplasia evAluated by oCT in de novo COROnary lesions treated by drug-eluting balloon and bare-metal stent (IN-PACT CORO): study protocol for a randomized controlled trial. Trials. 2012 May 6;13:55. doi: 10.1186/1745-6215-13-55.

• 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
• Last Update Posted: January 27, 2010
• Last Verified: January 2010

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; Albumin-Bound Paclitaxel; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action