AzTrials
AzTrials

Coronary Artery DiseaseROMANCT03217006

Randomization of Single vs Multiple Arterial Grafts

A study testing Single arterial graft and Multiple arterial grafting in people with Coronary Artery Disease and Heart Diseases, run by Weill Medical College of Cornell University at 59 sites in 17 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The primary hypothesis of ROMA is that in patients undergoing primary isolated non-emergent coronary artery bypass surgery (CABG), the use of two or more arterial grafts compared to a single arterial graft is associated with a reduction in the composite outcome of death from any cause, any stroke, post discharge… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Coronary Artery Disease, Heart Diseases
What is being tested?
Single arterial graft and Multiple arterial grafting
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,300 participants
Where
59 sitesin 17 countries
Study dates
7 Jan 2018to 31 Dec 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Primary isolated CABG patients with disease of the left main coronary artery and/or of the left anterior descending and the circumflex coronary system with or without disease of the right coronary artery.

Who cannot join

  • Age > 70 years
  • Single graft
  • Emergency operation
  • Evolving myocardial infarction within 48 hours of surgery
  • Left ventricular ejection fraction of < 35%
  • Any concomitant cardiac or non-cardiac procedure
Show all 11Show fewer
  • Previous cardiac surgery
  • Preoperative severe end-organ dysfunction (dialysis, liver failure, respiratory failure), cancer or any co-morbidity that reduce life expectancy to less than 5 years.
  • Inability to use the saphenous vein or to use both radial and right internal thoracic arteries
  • Anticipated need for coronary thrombo-endarterectomy
  • Planned hybrid revascularization

Trial locations and contacts

59 sites in 17 countries. Contact the study team or a site near you to ask about taking part.

Mario Gaudino, MD contact

212.746.1812

mfg9004@med.cornell.edu

Marshagay Rodriques contact

(212) 746-5594

mar4028@med.cornell.edu

59 sites in 17 countries

United States11 sites, 11 recruiting

  • University of Colorado

    Boulder, Colorado, 80309

    Jessica Rove

    Jessica Rove

    Recruiting

  • NewYork-Presbyterian Brooklyn Methodist Hospital

    Brooklyn, New York, 11215

    Sandhya Balaram, MD

    Sandhya Balaram, MD

    Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44106

    Faisal Bakaeen, bakaeef@ccf.org

    Faisal Bakaeen

    Recruiting

  • Nebraska Heart Hospital

    Lincoln, Nebraska, 68526

    Thomas Kleisli

    Thomas Kleisli

    Recruiting

  • Icahn School of Medicine, Mount Sinai

    New York, New York, 10029

    John Puskas, John.Puskas@mountsinai.org

    John Puskas

    Recruiting

  • Weil Cornell Medical College Department of Cardiothoracic Surgery

    New York, New York, 10065

    Mario FL Gaudino, MD, 212-746-1815, mfg9004@med.cornell.edu

    Nathan T Palaparthi, MS, 212-746-5194, ntp2001@med.cornell.edu

    Recruiting

  • Lenox Hill Hospital (Northwell)

    New York, New York, 10075

    Nirav Patel, nipatel@northwell.edu

    Nirav Patel

    Recruiting

  • NewYork-Presbyterian Queens

    New York, New York, 11355

    Charles Mack, MD

    Charles Mack, MD

    Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

    Aleem Siddique

    Aleem Siddique

    Recruiting

  • Allegheny General Hospital (Cardiovascular Institute)

    Pittsburgh, Pennsylvania, 15232

    Scott Halbreiner, Scott.halbreiner@ahn.org

    Scott Halbreiner

    Recruiting

  • Baystate Health

    Springfield, Massachusetts, 01109

    Daniel Engelman, Daniel.Engelman@baystatehealth.org

    Daniel Engelman

    Recruiting

Other trials in United States

Germany11 sites, 11 recruiting

  • Duisburg Heart Center

    Duisburg

    Jochen Börgermann, jochen.boergermann@evkln.de

    Jochen Börgermann

    Recruiting

  • Essen University

    Duisburg

    Matthias Klaus Thielmann, Matthias.Thielmann@uk-essen.de

    Matthias Klaus Thielmann

    Recruiting

  • Düsseldorf University

    Düsseldorf

    Alexander Assmann

    Alexander Assmann

    Recruiting

  • University Hospital Erlangen

    Erlangen

    Ehab Nooh, ehab.nooh@uk-erlangen.de

    Ehab Nooh

    Recruiting

  • Giessen Hospital

    Giessen

    Andreas Boening, andreas.boening@chiru.med.uni-giessen.de

    Andreas Boening

    Recruiting

  • University Medical Center of Goettingen

    Göttingen

    Enrolling by invitation

  • Jena University Hospital

    Jena

    Torsten Doenst

    Torsten Doenst

    Recruiting

  • Heart Center (Herzzentrum)

    Leipzig

    Michael Borger

    Michael Borger

    Recruiting

  • HDZ NRW Bad

    Oeynhausen

    Kavous Haikim- Meibodi, khakim-meibodi@hdz-nrw.de

    Kavous Haikim- Meibodi

    Recruiting

  • Robert-Bosch-Hospital

    Stuttgart

    Marc Albert, marc.albert@rbk.de

    Marc Alber

    Recruiting

  • Krankenhaus der Barmherzigen Brüder Trier

    Trier

    Terrence John Donovan

    Terrence John Donovan

    Recruiting

Other trials in Germany

Canada9 sites, 9 recruiting

  • Hamilton General Hospital

    Hamilton

    Andre Lamy, lamya@mcmaster.ca

    Andre Lamy

    Recruiting

  • London Health Sciences Ontario Canada

    London

    Michael Chu, Michael.chu@lhsc.on.ca

    Michael Chu

    Recruiting

  • University Hospital of Montreal (CHUM)

    Montreal

    Nicolas Noiseux

    Nicolas Noiseux

    Recruiting

  • University of Ottawa Heart Institute Canada

    Ottawa

    Marc Ruel, mruel@ottawaheart.ca

    Marc Ruel

    Recruiting

  • Royal Victoria Hospital (McGill)

    Québec

    Kevin Lachapelle,

    Kevin Lachapelle

    Recruiting

  • Universite Laval Quebec (CRIUCPQ) Canada

    Québec

    Pierre Voisine, pierre.voisine@chg.ulaval.ca

    Pierre Voisine

    Recruiting

  • Sunnybrook Health Sciences Centre

    Toronto

    Stephen Fremes, Stephen.Fremes@sunnybrook.ca

    Stephen Fremes

    Recruiting

  • Toronto General Hospital

    Toronto

    Vivek Rao

    Vivek Rao

    Recruiting

  • St. Boniface General Hospital / WHRA

    Winnipeg

    Rakesh Arora

    Rakesh Arora

    Recruiting

Other trials in Canada

Italy6 sites, 6 recruiting

  • Anthea Hospital

    Bari

    Giuseppe Speziale, gspeziale@gvmnet.it

    Giuseppe Speziale

    Recruiting

  • Fondazione Poliambulanza

    Brescia

    Gianni Troise, giovanni.troise@poliambulanza.it

    Gianni Troise

    Recruiting

  • Maria Cecilia Hospital GVM

    Cotignola

    Alberto Albertini

    Alberto Albertini

    Recruiting

  • Universita' Cattolica del Sacro Cuore

    Roma

    Massimo Massetti, massimo.massetti@unicatt.it

    Massimo Massetti

    Recruiting

  • European Hospital

    Rome

    Ruggero De Paulis, depauli@tin.it

    Ruggero De Paulis

    Recruiting

  • Ospedale Le Molinette

    Torino

    Mauro Rinaldi, mauro.rinaldi@unito.it

    Mauro Rinaldi

    Recruiting

Other trials in Italy

China5 sites, 5 recruiting

  • Fuwai Hospital

    Beijing

    Zhe Zheng, zhengzhe@fuwai.com

    Zhe Zheng

    Recruiting

  • Jilin Heart Hospital

    Changchun

    Massimo Lemma, dr.lemma@jlheart.org

    Massimo Lemma

    Recruiting

  • Ruijin Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai

    Qiang Zhao, zq11607@rjh.com.cn

    Qiang Zhao

    Recruiting

  • National Taiwan University Hospital

    Taiwan

    Yih-Sharng Chen, yschen1234@gmail.com

    Yih-Sharng Chen

    Recruiting

  • Teda Hospital (TICH)

    Tianjin

    Guo-Wei He, gwhezj@163.com

    Guo-Wei He

    Recruiting

Other trials in China

Austria3 sites, 3 recruiting

  • Innsbruck (Medical University) Austria

    Innsbruck

    Elfriede Ruttmann-Ulmer, Elfriede.Ruttmann@i-med.ac.at

    Elfriede Ruttmann-Ulmer

    Recruiting

  • Krankenhaus Nord Vienna North Hospital

    Vienna

    Berhard Winkler, bernhard.winkler@wienkav.at

    Berhard Winkler

    Recruiting

  • MU Vienna Austria

    Vienna

    Sigrid Sandner, sigrid.sandner@meduniwien.ac.at

    Sigrid Sandner

    Recruiting

Other trials in Austria

Portugal3 sites, 3 recruiting

  • Hospitalar de Lisboa Central

    Capuchos

    Miguel Sousa Uva

    Miguel Sousa Uva

    Recruiting

  • University Hospital (Praceta Mota Pinto)

    Coimbra

    Manuel Antunes, Mjantunes48@sapo.pt

    Manuel Antunes

    Recruiting

  • Centro Hospitalar e Universitário São João

    Porto

    Adelino Leite-Moreira

    Adelino Leite-Moreira

    Recruiting

Other trials in Portugal

Spain2 sites, 2 recruiting

  • Hospital Univeritario Del Vinalopo

    Alicante

    Jose Albors Martin

    Jose Albors Martin

    Recruiting

  • Hospital Clinic de Barcelona (ICCV)

    Barcelona

    Jorge Alcocer

    Jorge Alcocer

    Recruiting

Other trials in Spain

Brazil1 site, 1 recruiting

  • Federal University of Sao Paulo

    São Paulo

    Fabio Biscegli Jatene

    Fabio Biscegli Jatene

    Recruiting

Other trials in Brazil

Croatia1 site, 1 recruiting

  • University Hospital Dubrava

    Zagreb

    Igor Rudez, rudi@kbd.hr

    Igor Rudez

    Recruiting

Other trials in Croatia

Czechia1 site, 1 recruiting

  • General University Hospital, Prague

    Prague

    Tomas Prskavec

    Tomas Prskavec

    Recruiting

Other trials in Czechia

Japan1 site, 1 recruiting

  • Saitama Medical University

    Saitama

    Hiroyuki Nakajima, nakajim@saitama-med.ac.jp

    Hiroyuki Nakajima

    Recruiting

Other trials in Japan

Netherlands1 site, 1 recruiting

  • MUMC Maastricht (University Medical Centre)

    Maastricht

    Roberto Lorusso, Roberto.lorussobs@gmail.com;

    Roberto Lorusso

    Recruiting

Other trials in Netherlands

Poland1 site, 1 recruiting

  • Medical University of Silesia (Katowice)

    Katowice

    Mark Deja

    Mark Deja

    Recruiting

Other trials in Poland

Serbia1 site, 1 recruiting

  • Dedinje Cardiovascular Institute

    Belgrade

    Milan Milojevic, m.milojevic@erasmusmc.nl

    Milan Milojevic

    Recruiting

Other trials in Serbia

Singapore1 site, 1 recruiting

  • National University of Singapore

    Singapore

    Theodoros Kofidis, kofidis_theodoros@nuhs.edu.sg

    Theodoros Kofidis

    Recruiting

Other trials in Singapore

South Korea1 site, 1 recruiting

  • Severance Cardiovascular Hospital, Yonsei University College of Medicine

    Sinchŏn-dong

    Kyung-Jong Yoo, YSGS@yuhs.ac

    Kyung-Jong Yoo

    Recruiting

Other trials in South Korea

About this study

Official title: Randomized Comparison of the Clinical Outcome of Single Versus Multiple Arterial Grafts: the ROMA Trial

The primary hypothesis of ROMA is that in patients undergoing primary isolated non-emergent coronary artery bypass surgery (CABG), the use of two or more arterial grafts compared to a single arterial graft is associated with a reduction in the composite outcome of death from any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization. The secondary hypothesis is that in patients undergoing primary isolated non-emergent CABG, the use of two or more arterial grafts compared to a single arterial graft is associated with improved survival.

Prospective event-driven unblinded randomized multicenter trial of at least 4,300 subjects enrolled in at least 25 international centers. Patients will be randomized to a single arterial graft (SAG) or multiple arterial grafts (MAG). Patients will be randomized in a 1:1 fashion between the two groups. Permuted block randomization with random blocks stratified by the center and the type of second arterial graft will be used to provide treatment distribution in equal proportion.

Read the detailed description

In the 1980's, it was recognized that long-term survival was enhanced in patients undergoing coronary surgery when the left anterior descending (LAD) was grafted with a left internal thoracic artery (ITA) rather than a saphenous vein (1). This difference was predicated, at least in part, due to greater and more durable patency of the left ITA compared to an increased early occlusion rate and later progressive atherosclerosis of saphenous vein grafts (SVG) (2).

For more than 20 years it has generally been accepted that patients who receive multiple arterial grafts (AGs) at the time of coronary artery bypass surgery (CABG) have increased postoperative survival compared to those who receive only one AG, especially over the long term (3-5). The current United States and European Guidelines encourage the use of AGs in patients with a long life expectancy (6, 7). Last year, a position paper from the Society of Thoracic Surgeons strongly recommended a wider use of AGs (8).

The putative mechanism underlying the AG hypothesis is greater patency. In line with the original findings of improved LAD graft patency with ITA vs. SVG, data from randomized control trials (RCTs) as well as observational studies and a network meta-analysis (9) have demonstrated that the patency of the RA, as well as the right ITA, exceed that of a SVG, providing mechanistic basis to support the AG hypothesis.

ROMA is a two arm event driven randomized multi-centre trial aimed at evaluating the impact of the use of one ITA vs two or more AGs for CABG on a composite of death from any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization. The trial is powered to detect a 20% relative reduction in the primary outcome with 90% power at 5% alpha.

The primary aim is to conduct a multicenter international randomized control trial to test the hypothesis that the use of a two or more AGs compared to a single arterial graft is associated with a reduction in the composite outcome of death from any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization.

The secondary aim is to conduct a multicenter international randomized control trial to test the hypothesis that the use of two or more AGs compared to a single arterial graft is associated with improved survival.

Being tested
Single arterial graft, Multiple arterial grafting
Keywords
coronary artery bypass surgery, multiple arterial graft, radial artery graft
Medical subject headings
Coronary Artery Disease, Heart Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Single arterial graftProcedure or surgery

    This interventions consists of patients receiving the left internal thoracic artery to the left anterior descending coronary artery of the heart. In addition to the left internal thoracic artery patients will receive venous grafts for all additional grafting.

  • Multiple arterial graftingProcedure or surgery

    This intervention consists of the patient receiving the left internal thoracic artery to the left anterior descending coronary artery of the heart. The second arterial graft (right internal thoracic artery or radial artery) will be directed to the major branch of the circumflex. Additional grafts will include saphenous veins or arterial conduits.

Study groups in NCT03217006
Study groupRoleWhat they receive
Single Arterial GroupExperimentalPatients in this group will receive a single arterial graft which will be the left internal thoracic artery. Additional grafts used in this group will all be venous grafts.
Receives: Procedure: Single arterial graft
Multiple Arterial GroupExperimentalPatients in the group will receive multiple arterial grafts. All patients will receive at least two arterial grafts, the left internal thoracic artery with the addition of either the right internal thoracic artery or the radial artery as the second conduit. Some patients may receive additional arterial grafts consisting of the radial artery, the right internal thoracic artery, or the right gastroepiploic artery.
Receives: Procedure: Multiple arterial grafting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite Outcome

    A composite of death from any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization.

    Measured: > 72 hours after surgery and/or repeat revascularization

Secondary outcomes (7)

  1. 30-day mortality

    Death from any cause at 30-days

    Measured: 30 days post-operatively

  2. Major postoperative complications

    Revision for bleeding, perioperative myocardial infarction, any stroke, need for dialysis, need for tracheostomy, and surgical site infection.

    Measured: In-hospital stay, up to 30 days post-operatively

  3. Sternal wound complication

    Wound drainage, skin separation, unstable sternum, and sternal dehiscence, infection

    Measured: 6 months post-operatively

  4. Composite Outcome of Death from any cause

    A composite of death from any cause, post discharge myocardial infarction,stroke, and/or repeat revascularization

    Measured: Analysis will be performed after 631 events. The investigators assume this will occur at a mean follow-up of 5 years.

  5. Stroke

    Post discharge myocardial infarction and repeat revascularization considered as individual events

    Measured: Analysis will be performed after 631 events. The investigators assume this will occur at a mean follow-up of 5 years.

  6. Cause-specific death (cardiac vs non-cardiac)

    Death as either cardiac or non-cardiac in etiology

    Measured: Analysis will be performed after 631 events. The investigators assume this will occur at a mean follow-up of 5 years

  7. Hospital readmissions

    Hospital readmissions with specific causes

    Measured: Analysis will be performed after 631 events. The investigators assume this will occur at a mean follow-up of 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2017
  2. Study start7 Jan 2018
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients undergoing coronary artery bypass surgery will be in one of two groups. One group will receive a single arterial graft and the second group will receive two or more arterial grafts.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
4,300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03217006
Sponsor's protocol ID
1703018094
Other IDs
1R01HL152021-01
Acronym
ROMA
Status last verified
Aug 2026
First submitted
6 Jul 2017
Last updated
20 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Loop FD, Lytle BW, Cosgrove DM, Stewart RW, Goormastic M, Williams GW, Golding LA, Gill CC, Taylor PC, Sheldon WC, et al. Influence of the internal-mammary-artery graft on 10-year survival and other cardiac events. N Engl J Med. 1986 Jan 2;314(1):1-6. doi: 10.1056/NEJM198601023140101.

    PubMed 3484393

  • Tatoulis J, Buxton BF, Fuller JA. Patencies of 2127 arterial to coronary conduits over 15 years. Ann Thorac Surg. 2004 Jan;77(1):93-101. doi: 10.1016/s0003-4975(03)01331-6.

    PubMed 14726042

  • Lytle BW, Blackstone EH, Loop FD, Houghtaling PL, Arnold JH, Akhrass R, McCarthy PM, Cosgrove DM. Two internal thoracic artery grafts are better than one. J Thorac Cardiovasc Surg. 1999 May;117(5):855-72. doi: 10.1016/S0022-5223(99)70365-X.

    PubMed 10220677

  • Taggart DP, D'Amico R, Altman DG. Effect of arterial revascularisation on survival: a systematic review of studies comparing bilateral and single internal mammary arteries. Lancet. 2001 Sep 15;358(9285):870-5. doi: 10.1016/S0140-6736(01)06069-X.

    PubMed 11567701

  • Yi G, Shine B, Rehman SM, Altman DG, Taggart DP. Effect of bilateral internal mammary artery grafts on long-term survival: a meta-analysis approach. Circulation. 2014 Aug 12;130(7):539-45. doi: 10.1161/CIRCULATIONAHA.113.004255. Epub 2014 Jun 10.

    PubMed 24916209

  • Hillis LD, Smith PK, Anderson JL, Bittl JA, Bridges CR, Byrne JG, Cigarroa JE, Disesa VJ, Hiratzka LF, Hutter AM Jr, Jessen ME, Keeley EC, Lahey SJ, Lange RA, London MJ, Mack MJ, Patel MR, Puskas JD, Sabik JF, Selnes O, Shahian DM, Trost JC, Winniford MD. 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2011 Dec 6;124(23):e652-735. doi: 10.1161/CIR.0b013e31823c074e. Epub 2011 Nov 7. No abstract available.

    PubMed 22064599

  • Authors/Task Force members; Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29. No abstract available.

    PubMed 25173339

  • Aldea GS, Bakaeen FG, Pal J, Fremes S, Head SJ, Sabik J, Rosengart T, Kappetein AP, Thourani VH, Firestone S, Mitchell JD; Society of Thoracic Surgeons. The Society of Thoracic Surgeons Clinical Practice Guidelines on Arterial Conduits for Coronary Artery Bypass Grafting. Ann Thorac Surg. 2016 Feb;101(2):801-9. doi: 10.1016/j.athoracsur.2015.09.100. Epub 2015 Dec 8.

    PubMed 26680310

  • Benedetto U, Raja SG, Albanese A, Amrani M, Biondi-Zoccai G, Frati G. Searching for the second best graft for coronary artery bypass surgery: a network meta-analysis of randomized controlled trialsdagger. Eur J Cardiothorac Surg. 2015 Jan;47(1):59-65; discussion 65. doi: 10.1093/ejcts/ezu111. Epub 2014 Mar 30.

    PubMed 24686003

  • Nasso G, Coppola R, Bonifazi R, Piancone F, Bozzetti G, Speziale G. Arterial revascularization in primary coronary artery bypass grafting: Direct comparison of 4 strategies--results of the Stand-in-Y Mammary Study. J Thorac Cardiovasc Surg. 2009 May;137(5):1093-100. doi: 10.1016/j.jtcvs.2008.10.029. Epub 2009 Feb 7.

    PubMed 19379973

  • Taggart DP, Altman DG, Gray AM, Lees B, Gerry S, Benedetto U, Flather M; ART Investigators. Randomized Trial of Bilateral versus Single Internal-Thoracic-Artery Grafts. N Engl J Med. 2016 Dec 29;375(26):2540-9. doi: 10.1056/NEJMoa1610021. Epub 2016 Nov 14.

    PubMed 27959712

  • Zhang H, Wang ZW, Wu HB, Hu XP, Zhou Z, Xu P. Radial artery graft vs. saphenous vein graft for coronary artery bypass surgery : which conduit offers better efficacy? Herz. 2014 Jun;39(4):458-65. doi: 10.1007/s00059-013-3848-5. Epub 2013 Jun 21.

    PubMed 23784362

  • Harskamp RE, Alexander JH, Ferguson TB Jr, Hager R, Mack MJ, Englum B, Wojdyla D, Schulte PJ, Kouchoukos NT, de Winter RJ, Gibson CM, Peterson ED, Harrington RA, Smith PK, Lopes RD. Frequency and Predictors of Internal Mammary Artery Graft Failure and Subsequent Clinical Outcomes: Insights From the Project of Ex-vivo Vein Graft Engineering via Transfection (PREVENT) IV Trial. Circulation. 2016 Jan 12;133(2):131-8. doi: 10.1161/CIRCULATIONAHA.115.015549. Epub 2015 Dec 8.

    PubMed 26647082

  • Lopes RD, Mehta RH, Hafley GE, Williams JB, Mack MJ, Peterson ED, Allen KB, Harrington RA, Gibson CM, Califf RM, Kouchoukos NT, Ferguson TB Jr, Alexander JH; Project of Ex Vivo Vein Graft Engineering via Transfection IV (PREVENT IV) Investigators. Relationship between vein graft failure and subsequent clinical outcomes after coronary artery bypass surgery. Circulation. 2012 Feb 14;125(6):749-56. doi: 10.1161/CIRCULATIONAHA.111.040311. Epub 2012 Jan 11.

    PubMed 22238227

  • Shavadia J, Norris CM, Graham MM, Verma S, Ali I, Bainey KR. Symptomatic graft failure and impact on clinical outcome after coronary artery bypass grafting surgery: Results from the Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease registry. Am Heart J. 2015 Jun;169(6):833-40. doi: 10.1016/j.ahj.2015.02.022. Epub 2015 Mar 13.

    PubMed 26027621

Questions about this trial

What is this clinical trial studying?

A study testing Single arterial graft and Multiple arterial grafting in people with Coronary Artery Disease and Heart Diseases, run by Weill Medical College of Cornell University at 59 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States, Germany, Canada, Italy, China and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mario Gaudino, MD (212.746.1812, mfg9004@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite Outcome (time frame: > 72 hours after surgery and/or repeat revascularization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03217006, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.

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Randomization of Single vs Multiple Arterial Grafts | AzTrials