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Feasibility of Orbital Atherectomy System in Calcified Bifurcation Lesion (ORBID-OA)

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: NCT03058510
Recruitment Status : Completed
First Posted : February 23, 2017
Last Update Posted : December 8, 2017
Sponsor:
Collaborator:
Cardiovascular Systems Inc
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Brief Summary:

ORBID-OA is a single-center, observational study in 30 patients with stable coronary artery disease.

The aim of the study is to analyze the outcomes of main vessel stenting on side branch in calcified bifurcation lesion and identify preprocedural predictors of side branch complication by utilizing two-dimensional (2D) and three-dimensional (3D) frequency domain optical coherence tomography (FD-OCT).


Condition or disease Intervention/treatment
Coronary Artery Disease Procedure: Frequency domain optical coherence tomography

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Feasibility of Orbital Atherectomy System in Calcified Bifurcation Lesion
Actual Study Start Date : January 17, 2016
Actual Primary Completion Date : October 13, 2017
Actual Study Completion Date : October 13, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Stable CAD Patients
Stable CAD patients with calcified bifurcation lesion
Procedure: Frequency domain optical coherence tomography
OCT is an established medical imaging technique that uses light to capture high-resolution, three-dimensional images of blood vessels
Other Names:
  • coronary angiogram
  • FD OCT




Primary Outcome Measures :
  1. Procedural success [ Time Frame: Day 1 ]
    Incidence of placing a stent with less than 50% residual stenosis


Secondary Outcome Measures :
  1. Acute angiographic complications [ Time Frame: Day 1 ]
    Incidence of acute angiographic complications



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
Thirty consecutive patients with calcified lesions requiring PCI of main vessel with drug eluting stent implantation for the treatment of stable CAD will be included in the study.
Criteria

Inclusion Criteria:

  • All patients over 18 years of age presenting with stable coronary artery disease.
  • Angiographic lesion with severe calcification with or without side branch (SB) in whom provisional main vessel stenting strategy is planned after reviewing angiogram will be recruited

Exclusion Criteria:

  • Patients with ostial left main artery lesions or ostial right coronary artery lesions
  • Female patients with child bearing potential not taking adequate contraceptives or currently breastfeeding
  • Known allergy to acetylsalicylic acid or clopidogrel.
  • Planned surgery within 12 months.
  • History of bleeding diathesis
  • Major surgery within 15 days
  • Life expectancy < 12 months.
  • Patients with kidney dysfunction (CrCl<30)

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): NCT03058510


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai and the Mount Sinai Hospital
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Cardiovascular Systems Inc
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: NCT03058510    
Other Study ID Numbers: GCO 16-1561
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017
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:
bifurcation lesion
atherectomy
calcification
stent
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases