NCT03058510

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

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

January 17, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2017

Completed
Last Updated

December 8, 2017

Status Verified

December 1, 2017

Enrollment Period

1.7 years

First QC Date

February 16, 2017

Last Update Submit

December 6, 2017

Conditions

Coronary Artery Disease

Keywords

bifurcation lesionatherectomycalcificationstent

Outcome Measures

Primary Outcomes (1)

  • Procedural success

    Incidence of placing a stent with less than 50% residual stenosis

    Day 1

Secondary Outcomes (1)

  • Acute angiographic complications

    Day 1

Study Arms (1)

Stable CAD Patients

Stable CAD patients with calcified bifurcation lesion

Procedure: Frequency domain optical coherence tomography

Interventions

Frequency domain optical coherence tomographyPROCEDURE

OCT is an established medical imaging technique that uses light to capture high-resolution, three-dimensional images of blood vessels

Also known as: coronary angiogram, FD OCT
Stable CAD Patients

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai and the Mount Sinai Hospital

New York, New York, 10029, United States

Location

Related Publications (12)

  • Al Suwaidi J, Berger PB, Rihal CS, Garratt KN, Bell MR, Ting HH, Bresnahan JF, Grill DE, Holmes DR Jr. Immediate and long-term outcome of intracoronary stent implantation for true bifurcation lesions. J Am Coll Cardiol. 2000 Mar 15;35(4):929-36. doi: 10.1016/s0735-1097(99)00648-8.

    PMID: 10732890BACKGROUND

  • Iakovou I, Ge L, Colombo A. Contemporary stent treatment of coronary bifurcations. J Am Coll Cardiol. 2005 Oct 18;46(8):1446-55. doi: 10.1016/j.jacc.2005.05.080. Epub 2005 Sep 28.

    PMID: 16226167BACKGROUND

  • Sharma SK, Sweeny J, Kini AS. Coronary bifurcation lesions: a current update. Cardiol Clin. 2010 Feb;28(1):55-70. doi: 10.1016/j.ccl.2009.10.001.

    PMID: 19962049BACKGROUND

  • Writing Group Members; Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jimenez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Executive Summary: Heart Disease and Stroke Statistics--2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):447-54. doi: 10.1161/CIR.0000000000000366. No abstract available.

    PMID: 26811276BACKGROUND

  • Moussa I, Ellis SG, Jones M, Kereiakes DJ, McMartin D, Rutherford B, Mehran R, Collins M, Leon MB, Popma JJ, Russell ME, Stone GW. Impact of coronary culprit lesion calcium in patients undergoing paclitaxel-eluting stent implantation (a TAXUS-IV sub study). Am J Cardiol. 2005 Nov 1;96(9):1242-7. doi: 10.1016/j.amjcard.2005.06.064. Epub 2005 Sep 15.

    PMID: 16253590BACKGROUND

  • Parikh K, Chandra P, Choksi N, Khanna P, Chambers J. Safety and feasibility of orbital atherectomy for the treatment of calcified coronary lesions: the ORBIT I trial. Catheter Cardiovasc Interv. 2013 Jun 1;81(7):1134-9. doi: 10.1002/ccd.24700. Epub 2013 Mar 5.

    PMID: 23460596BACKGROUND

  • Karanasos A, Tu S, van der Heide E, Reiber JH, Regar E. Carina shift as a mechanism for side-branch compromise following main vessel intervention: insights from three-dimensional optical coherence tomography. Cardiovasc Diagn Ther. 2012 Jun;2(2):173-7. doi: 10.3978/j.issn.2223-3652.2012.04.01. No abstract available.

    PMID: 24282711BACKGROUND

  • Suarez de Lezo J, Medina A, Martin P, Novoa J, Suarez de Lezo J, Pan M, Caballero E, Melian F, Mazuelos F, Quevedo V. Predictors of ostial side branch damage during provisional stenting of coronary bifurcation lesions not involving the side branch origin: an ultrasonographic study. EuroIntervention. 2012 Feb;7(10):1147-54. doi: 10.4244/EIJV7I10A185.

    PMID: 22030298BACKGROUND

  • Farooq V, Serruys PW, Heo JH, Gogas BD, Okamura T, Gomez-Lara J, Brugaletta S, Garcia-Garcia HM, van Geuns RJ. New insights into the coronary artery bifurcation hypothesis-generating concepts utilizing 3-dimensional optical frequency domain imaging. JACC Cardiovasc Interv. 2011 Aug;4(8):921-31. doi: 10.1016/j.jcin.2011.06.004.

    PMID: 21851908BACKGROUND

  • 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, Raber 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.

    PMID: 22421299BACKGROUND

  • Di Mario C, Iakovou I, van der Giessen WJ, Foin N, Adrianssens T, Tyczynski P, Ghilencea L, Viceconte N, Lindsay AC. Optical coherence tomography for guidance in bifurcation lesion treatment. EuroIntervention. 2010 Dec;6 Suppl J:J99-J106. doi: 10.4244/EIJV6SUPJA16.

    PMID: 21930500BACKGROUND

  • Karanasos A, Tu S, van der Linden M, van Weenen S, Ligthart J, Regar E. Online 3-dimensional rendering of optical coherence tomography images for the assessment of bifurcation intervention. Can J Cardiol. 2012 Nov-Dec;28(6):759.e1-3. doi: 10.1016/j.cjca.2012.04.017. Epub 2012 Jul 3.

    PMID: 22763361BACKGROUND

MeSH Terms

Conditions

Coronary Artery DiseaseCalcinosis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Annapoorna Kini, MD MRCP FACC

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2017

First Posted

February 23, 2017

Study Start

January 17, 2016

Primary Completion

October 13, 2017

Study Completion

October 13, 2017

Last Updated

December 8, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)