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BVS-OCT Imaging Study

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ClinicalTrials.gov Identifier: NCT03194711
Recruitment Status : Completed
First Posted : June 21, 2017
Last Update Posted : May 7, 2018
Sponsor:
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Brief Summary:
The single center retrospective study evaluates the acute and long term outcomes of bioabsorbable drug-eluting scaffolds (BVS) implantation in 50 consecutive coronary artery disease (CAD) patients using optical coherence tomography (OCT) imaging.

Condition or disease Intervention/treatment
Coronary Disease Device: BVS implantation

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Bioabsorbable Drug-eluting Scaffolds (BVS)-Optical Coherence Tomography (OCT) Imaging Study
Actual Study Start Date : May 30, 2017
Actual Primary Completion Date : April 17, 2018
Actual Study Completion Date : April 17, 2018

Group/Cohort Intervention/treatment
Patients with stable CAD Device: BVS implantation
BVS implantation using conventional semicompliant or non-compliant balloon




Primary Outcome Measures :
  1. Acute lumen gain by quantitative coronary angiography (QCA) [ Time Frame: 1 year ]
    Acute lumen gain after BVS implantation by quantitative coronary angiography (QCA)

  2. Acute lumen gain by Optical Coherence Tomography (OCT) [ Time Frame: 1 year ]
    Acute lumen gain after BVS implantation by OCT


Secondary Outcome Measures :
  1. Major adverse cardiac events [ Time Frame: 1 year ]
    Major adverse cardiac events, defined as a composite of cardiac death, myocardial infarction, and target lesion



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Mount Sinai Catheterization laboratory patients who who underwent PCI with BVS implantation and OCT imaging for treatment of CAD
Criteria

Inclusion Criteria:

  • Consecutive patients who underwent PCI with BVS implantation and OCT imaging for treatment of CAD

Exclusion Criteria:

  • None

Information from the National Library of Medicine

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): NCT03194711


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Annapoorna Kini, MD, MRCP, FACC Icahn School of Medicine at Mount Sinai

Publications:
Tearney GJ, Regar E, Akasaka T, Adriaenssens T, Barlis P, Bezerra HG, Bouma B, Bruining N, Cho JM, Chowdhary S, Costa MA, de Silva R, Dijkstra J, Di Mario C, Dudek D, Falk E, Feldman MD, Fitzgerald P, Garcia-Garcia HM, Gonzalo N, Granada JF, Guagliumi G, Holm NR, Honda Y, Ikeno F, Kawasaki M, Kochman J, Koltowski L, Kubo T, Kume T, Kyono H, Lam CC, Lamouche G, Lee DP, Leon MB, Maehara A, Manfrini O, Mintz GS, Mizuno K, Morel MA, Nadkarni S, Okura H, Otake H, Pietrasik A, Prati F, Räber L, Radu MD, Rieber J, Riga M, Rollins A, Rosenberg M, Sirbu V, Serruys PW, Shimada K, Shinke T, Shite J, Siegel E, Sonoda S, Suter M, Takarada S, Tanaka A, Terashima M, Thim T, Uemura S, Ughi GJ, van Beusekom HM, van der Steen AF, van Es GA, van Soest G, Virmani R, Waxman S, Weissman NJ, Weisz G; International Working Group for Intravascular Optical Coherence Tomography (IWG-IVOCT). Consensus standards for acquisition, measurement, and reporting of intravascular optical coherence tomography studies: a report from the International Working Group for Intravascular Optical Coherence Tomography Standardization and Validation. J Am Coll Cardiol. 2012 Mar 20;59(12):1058-72. doi: 10.1016/j.jacc.2011.09.079. Erratum in: J Am Coll Cardiol. 2012 May 1;59(18):1662. Dudeck, Darius [corrected to Dudek, Darius]; Falk, Erlin [corrected to Falk, Erling]; Garcia, Hector [corrected to Garcia-Garcia, Hector M]; Sonada, Shinjo [corrected to Sonoda, Shinjo]; Troels, Thim [corrected to Thim, Troels]; van Es, Gerrit-Ann [correct.

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Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03194711     History of Changes
Other Study ID Numbers: GCO 16-2757
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Icahn School of Medicine at Mount Sinai:
Percutaneous Coronary Revascularization
Optical Coherence Tomography
Stents, Drug-Eluting
Additional relevant MeSH terms:
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Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases