NCT01057563

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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Last Updated

January 27, 2010

Status Verified

January 1, 2010

Enrollment Period

1 year

First QC Date

January 26, 2010

Last Update Submit

January 26, 2010

Conditions

Coronary Artery Disease

Keywords

Coronary artery diseaseNeointimal hyperplasiaDrug-eluting balloonOptical coherence tomography

Outcome Measures

Primary Outcomes (1)

  • Primary Endpoint: Neo-intimal area (mm²).

    6 months post procedure

Secondary Outcomes (1)

  • Secondary Endpoints: - 6m percentage of uncovered struts. - 6m percentage of struts with ISA. - 6m percentage of protruding struts.

    6 months post procedure

Study Arms (3)

BMS group

ACTIVE COMPARATOR

Patients undergoing PCI with BMS implantation

Device: bare-metal stent (BMS)

PRE-DEB group

ACTIVE COMPARATOR

Patients undergoing PCI with BMS implantation after lesion predilation with DEB

Device: drug (paclitaxel)-eluting balloon (DEB)

POST-DEB group

ACTIVE COMPARATOR

Patients undergoing PCI with BMS implantation followed by postdilation with DEB

Device: Drug (paclitaxel)-eluting balloon (DEB)

Interventions

Drug (paclitaxel)-eluting balloon (DEB)DEVICE

BMS implantation after lesion predilation with DEB

PRE-DEB group
bare-metal stent (BMS)DEVICE

BMS implantation

BMS group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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,
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Cardiology, Catholic University of Sacred Heart

Rome, 00168, Italy

RECRUITING

Related Publications (11)

  • 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. doi: 10.2165/00129784-200404040-00006.

    PMID: 15285700BACKGROUND

  • 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.

    PMID: 19487593BACKGROUND

  • Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Bohm 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. doi: 10.1056/NEJMoa061254. Epub 2006 Nov 13.

    PMID: 17101615BACKGROUND

  • Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Bohm 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.

    PMID: 18536865BACKGROUND

  • 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. doi: 10.4244/eijv3i3a66.

    PMID: 19737719BACKGROUND

  • 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. doi: 10.1136/hrt.2007.118679.

    PMID: 17923466BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 19463468BACKGROUND

  • 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.

    PMID: 25863804DERIVED

  • 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.

    PMID: 25465324DERIVED

  • 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.

    PMID: 22559260DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical PreparationsTechnology, PharmaceuticalInvestigative Techniques

Study Officials

  • Francesco Burzotta, MD, PhD

    Catholic University of Sacred Heart

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Burzotta, MD, PhD

CONTACT

39-349-4295290f.burzotta@rm.unicatt.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 26, 2010

First Posted

January 27, 2010

Study Start

November 1, 2009

Primary Completion

November 1, 2010

Last Updated

January 27, 2010

Record last verified: 2010-01

Locations

IT(1)