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CompletedNCT03447197Updated Feb 27, 2018

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

An interventional study of The use of extracorporeal circulation in Coronary Artery Stenoses, sponsored by Örebro County Council. Completed. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2018-02-27.

Sponsored by Örebro County Council · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
59
Allocation
Randomized
Ages
55 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Coronary Artery Stenoses

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03

Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients were eligible if they:

    1. provided written informed consent;
    2. were >21 years of age;
    3. required isolated CABG with median sternotomy;
    4. had at least one of the following risk factors:

      1. had peripheral vascular disease (previous peripheral bypass, amputation or anklebranchial index \<0.90),
      2. had cerebrovascular disease (history of stroke, transient ischemic attach or carotid stenosis ≥70%),
      3. had renal insufficiency (creatinine above upper limit of normal),
      4. were ≥70 years of age, or
      5. 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
      6. 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

Exclusion Criteria:

  • Patients were excluded if they:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
59 participants (actual)

Study arms

  • Active comparator
    On-Pump

    Use of extracorporeal circulation

    Procedure: The use of extracorporeal circulation

  • No intervention
    Off-Pump

Interventions

  • ProcedureThe use of extracorporeal circulation

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

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What researchers measure

Primary outcomes

  1. Graft patency

    Graft patency as assessed with computed tomography angiography

    Time frame: Five years postoperatively

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03447197
Lead sponsor
Örebro County Council
Responsible party
Ninos Samano M.D. (Consultant in Cardiothoracic Surgery, Örebro County Council) — Principal investigator
First posted
Feb 27, 2018
Start date
Sep 1, 2015
Primary completion
Dec 31, 2016
Completion
Dec 31, 2017
Last update
Feb 27, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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