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Completed

NCT Number: NCT03447197

Five-year Patency of No-touch Saphenous Vein Grafts in On-pump Versus Clamp-less Off-pump Coronary Artery Bypass Surgery

Randomised controlled trials (RCTs) have shown high long-term patency for no-touch saphenous vein grafts (NTSVGs), comparable to the internal thoracic artery in on-pump coronary artery bypass grafting (CABG). RCTs on patency in NTSVGs in off-pump CABG have not been published yet. Orebro University Hospital participated in the CABG Off- or On-pump Revascularization study (CORONARY, ClinicalTrials.gov number, NCT00463294) and included fifty-six patients. Accordingly, this is a sub-study and the aim was to assess the midterm patency in NTSVGs in clamp-less off-pump versus on-pump CABG at five-year follow-up.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients were eligible if they:
  • provided written informed consent;
  • were >21 years of age;
  • required isolated CABG with median sternotomy;
  • had at least one of the following risk factors:
  • had peripheral vascular disease (previous peripheral bypass, amputation or anklebranchial index <0.90),
  • had cerebrovascular disease (history of stroke, transient ischemic attach or carotid stenosis ≥70%),
  • had renal insufficiency (creatinine above upper limit of normal),
  • were ≥70 years of age, or
  • were between the ages of 60-69 with one of the following: i. had diabetes and taking an oral hypoglycemic agent and/or insulin, ii. required urgent revascularization (i.e., waiting in hospital for revascularization after an acute coronary syndrome), iii. were a recent smoker (within 1 year of randomization), or iv. had left ventricular ejection fraction ≤35%, OR
  • were between the ages of 55-59 with two of the following: i. Diabetes and taking an oral hypoglycemic agent and/or insulin, ii. required urgent revascularization (i.e., waiting in hospital for revascularization after an acute coronary syndrome, iii. were a recent smoker (within 1 year of randomization), or iv. had a left ventricular ejection fraction ≤35%

Exclusion criteria

  • Patients were excluded if they:
  • required a concomitant cardiac procedure associated with CABG;
  • had a contraindication to off-pump or on-pump CABG (e.g., calcified aorta, intramuscular left anterior descending artery, calcified coronaries, small target vessels);
  • had a concomitant life-threatening disease likely to limit life expectancy to less than 2 years;
  • were previously enrollment in the CORONARY Trial;
  • required emergency CABG surgery (i.e., immediate revascularization for hemodynamic instability); OR
  • required a redo CABG.

Treatment and study plan

The use of extracorporeal circulation

Procedure

The use or not of extracorporeal circulation during the coronary artery bypass procedure.

Primary outcomes

  1. Graft patency

    Time frame: Five years postoperatively

    Graft patency as assessed with computed tomography angiography

Sponsors and collaborators

Lead sponsor

Örebro County Council

Other Gov

Registry information

Official study title

Five-year Patency of No-touch Saphenous Vein Grafts in On-pump Versus Clamp-less Off-pump Coronary Artery Bypass Surgery: A Sub-study of a Multicenter Randomized Controlled Trial

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Feb 27, 2018
Registry last updated
Feb 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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