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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

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

Sponsor:

Information provided by:

Catholic University of the Sacred Heart

No Study Results Posted on ClinicalTrials.gov for this Study

About Study Results Reporting on ClinicalTrials.gov

Recruitment Status :	Unknown
Estimated Primary Completion Date :	November 2010
Study Completion Date :	No date given

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.

To Top