Back to results

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

Primary Purpose

Coronary Artery Stenoses

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

The use of extracorporeal circulation

About this trial

This is an interventional treatment trial for Coronary Artery Stenoses

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

On-Pump

Off-Pump

Arm Description

Use of extracorporeal circulation

Outcomes

Primary Outcome Measures

Graft patency

Graft patency as assessed with computed tomography angiography

Secondary Outcome Measures

Full Information

NCT ID

NCT03447197

First Posted

February 20, 2018

Last Updated

February 25, 2018

Sponsor

Örebro County Council

1. Study Identification

Unique Protocol Identification Number

NCT03447197

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

September 1, 2015 (Actual)

Primary Completion Date

December 31, 2016 (Actual)

Study Completion Date

December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Örebro County Council

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Stenoses

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

59 (Actual)

8. Arms, Groups, and Interventions

Arm Title

On-Pump

Arm Type

Active Comparator

Arm Description

Use of extracorporeal circulation

Arm Title

Off-Pump

Arm Type

No Intervention

Intervention Type

Procedure

Intervention Name(s)

The use of extracorporeal circulation

Intervention Description

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

Primary Outcome Measure Information:

Title

Graft patency

Description

Graft patency as assessed with computed tomography angiography

Time Frame

Five years postoperatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs