No-Touch Versus Conventional Saphenous Vein Harvesting Technique
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
No-Touch vein harvesting technique
Conventional vein harvesting
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring coronary artery disease, coronary artery bypass graft
Eligibility Criteria
Inclusion Criteria:
- Patients receiving first time isolated on-pump/off-pump CABG
- Patients with at least one available saphenous vein graft
Exclusion Criteria:
- Need for a concomitant cardiac or vascular surgeries (i.e. valve repair or replacement, Maze surgery)
- Redo-CABG
- Emergent CABG
- Using vascular stapler for anastomosis
- Endarterectomy of coronary artery during surgery
- Left ventricular repair due to ventricular aneurysm
- Combined with malignant tumor or other severe systemic conditions
- Severe renal insufficiency (i.e. creatinine >200 μmol/L)
- Contraindications for dual antiplatelet therapy, such as active gastroduodenal ulcer
- Participants of another ongoing clinical trials
Sites / Locations
- Fuwai Hospital Chinese Academay of Medical Science and National Center for Cardiovascular Diseases
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
No-Touch vein harvesting technique
Conventional vein harvesting
Arm Description
During saphenous vein harvesting, surrounding tissue of the vein is preserved, and manual distension of the vein graft is avoided
During saphenous vein harvesting, surrounding tissue of the vein is stripped off, and manual distension is routinely performed
Outcomes
Primary Outcome Measures
Prevalence of graft occlusion
All participants will be invited to return to their operating hospitals for 64-slice multi-slice computed tomography angiography to determine patencies of the graft vessels.
Secondary Outcome Measures
Prevalence of graft occlusion
All participants will be invited to return to their operating hospitals for 64-slice multi-slice computed tomography angiography to determine patencies of the graft vessels.
Overall major adverse cardiac or cerebrovascular events (MACCE) rate
MACCE includes death, myocardial infarction, stroke and/or repeat revascularization
Cardiac death
death from any heart disease
Documented non-lethal myocardial infarction
Myocardial infarction is defined according to the most recent guideline
Stroke
an acute symptomatic episode of focal or global neurological dysfunction caused by brain, spinal, or retinal vascular injury as a result of hemorrhage or infarction
Target lesion revascularization
CABG or percutaneous coronary intervention
Recurrence of Angina
recurrence of unstable angina
Full Information
NCT ID
NCT03126409
First Posted
April 19, 2017
Last Updated
July 12, 2020
Sponsor
China National Center for Cardiovascular Diseases
1. Study Identification
Unique Protocol Identification Number
NCT03126409
Brief Title
No-Touch Versus Conventional Saphenous Vein Harvesting Technique
Official Title
A Multicenter Randomized Trial to Compare the Graft Patency Between No-Touch Vein Harvesting Technique and Conventional Approach in Coronary Artery Bypass Graft Surgery: the PATENCY Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 14, 2017 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
December 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China National Center for Cardiovascular Diseases
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study evaluates the short-term patency of vein graft harvested by the No-Touch technique compared to that by the conventional approach in patients undergoing isolated on-pump/off-pump coronary artery bypass graft (CABG) surgery. a total of at least 2000 patients undergoing isolated on-pump/off-pump CABG will be consecutively recruited from 7 hospitals across China and randomly assigned to receive No-Touch saphenous vein harvesting or conventional approach. All participants will be invited for clinical follow-up and 64-slice multislice computed tomography angiography (MSCTA) analysis at 3 months post-operatively.
Detailed Description
CABG is still the treatment of choice for ischemic heart disease. However, restenosis or occlusion may occur to graft vessels, leading to postoperative myocardial ischemia and subsequent clinical events. Long-term angiographic follow-up demonstrated that vein graft restenosis and occlusion are common among those receiving CABG, with a vein graft patency of less than 50% at 15 years postoperatively. Besides, it is found that graft occlusion may occur as early as 3 months after the surgery. It is, therefore, a major priority to improve the short-term postoperative vein graft patency so as to achieve better prognosis for patients.
Saphenous vein, the currently most frequently used graft material, occupies over 70% of all graft vessels.
Multiple factors may contribute to the early restenosis or occlusion of the vein grafts, including anastomosis technique, graft vessel quality, target lesion site and degree of stenosis, perioperative coagulating function, etc. The No-Touch technique focuses on saphenous vein graft harvesting, featured by preserving the surrounding tissue of the vein while at the same time avoiding manual distension. This technique has been reported associated with better short and long-term vein graft patency. However, these results mostly came from small-scale, single-center studies, therefore could hardly be recognized as high-level evidence for generalization of the technique.
This prospective multi-center study aims to compare the short-term saphenous vein graft patency harvested by the No-Touch technique and the conventional approach. This study will consecutively enroll 2000 patients undergoing isolated on-pump/off-pump CABG in 7 hospitals of China. After obtaining informed written consent, participants will be randomly allocated to either the No-Touch harvesting or conventional approach group. At baseline, participants will be interviewed to collect detailed information about on demographics, socioeconomic status, cardiovascular risk factors, clinical characteristics, treatments, in-hospital outcomes, general and disease-specific quality of life, function and mental status. During the follow-ups, the investigators will collect information about clinical outcomes events, long-term treatments, function, quality of life, symptoms, and medical care during the recovery period. All participants will be invited for 64-slice multi-slice computed tomography angiography (MSCTA) analysis at 3 months post-operatively for graft patency evaluation.
The patients, data adjudicators and CT reviewers will be blinded to the study. Due to the nature of this study, the operating surgeons, anesthetists and other operative room staff will not be blind in this study.
By comparing the short-term graft patency between the No-Touch and conventional vein harvesting groups, this study will contribute major evidence of the possible superiority of this technique, so as to improve patient outcomes after CABG surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
coronary artery disease, coronary artery bypass graft
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2655 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No-Touch vein harvesting technique
Arm Type
Experimental
Arm Description
During saphenous vein harvesting, surrounding tissue of the vein is preserved, and manual distension of the vein graft is avoided
Arm Title
Conventional vein harvesting
Arm Type
Active Comparator
Arm Description
During saphenous vein harvesting, surrounding tissue of the vein is stripped off, and manual distension is routinely performed
Intervention Type
Procedure
Intervention Name(s)
No-Touch vein harvesting technique
Intervention Description
The No-Touch technique focuses on saphenous vein graft harvesting, featured by preserving the surrounding tissue of the vein while at the same time avoiding manual distension.
Intervention Type
Procedure
Intervention Name(s)
Conventional vein harvesting
Intervention Description
During saphenous vein harvesting, surrounding tissue of the vein is stripped off, and manual distension is routinely performed
Primary Outcome Measure Information:
Title
Prevalence of graft occlusion
Description
All participants will be invited to return to their operating hospitals for 64-slice multi-slice computed tomography angiography to determine patencies of the graft vessels.
Time Frame
3 month after procedure
Secondary Outcome Measure Information:
Title
Prevalence of graft occlusion
Description
All participants will be invited to return to their operating hospitals for 64-slice multi-slice computed tomography angiography to determine patencies of the graft vessels.
Time Frame
1 year after procedure
Title
Overall major adverse cardiac or cerebrovascular events (MACCE) rate
Description
MACCE includes death, myocardial infarction, stroke and/or repeat revascularization
Time Frame
3 month and 1 year after procedure
Title
Cardiac death
Description
death from any heart disease
Time Frame
3 month and 1 year after procedure
Title
Documented non-lethal myocardial infarction
Description
Myocardial infarction is defined according to the most recent guideline
Time Frame
3 month and 1 year after procedure
Title
Stroke
Description
an acute symptomatic episode of focal or global neurological dysfunction caused by brain, spinal, or retinal vascular injury as a result of hemorrhage or infarction
Time Frame
3 month and 1 year after procedure
Title
Target lesion revascularization
Description
CABG or percutaneous coronary intervention
Time Frame
3 month and 1 year after procedure
Title
Recurrence of Angina
Description
recurrence of unstable angina
Time Frame
3 month and 1 year after procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients receiving first time isolated on-pump/off-pump CABG
Patients with at least one available saphenous vein graft
Exclusion Criteria:
Need for a concomitant cardiac or vascular surgeries (i.e. valve repair or replacement, Maze surgery)
Redo-CABG
Emergent CABG
Using vascular stapler for anastomosis
Endarterectomy of coronary artery during surgery
Left ventricular repair due to ventricular aneurysm
Combined with malignant tumor or other severe systemic conditions
Severe renal insufficiency (i.e. creatinine >200 μmol/L)
Contraindications for dual antiplatelet therapy, such as active gastroduodenal ulcer
Participants of another ongoing clinical trials
Facility Information:
Facility Name
Fuwai Hospital Chinese Academay of Medical Science and National Center for Cardiovascular Diseases
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30743210
Citation
Wang X, Tian M, Zheng Z, Gao H, Wang Y, Wang L, Hu S. Rationale and design of a multicenter randomized trial to compare the graft patency between no-touch vein harvesting technique and conventional approach in coronary artery bypass graft surgery. Am Heart J. 2019 Apr;210:75-80. doi: 10.1016/j.ahj.2018.11.011. Epub 2018 Dec 6.
Results Reference
background
PubMed Identifier
34510911
Citation
Tian M, Wang X, Sun H, Feng W, Song Y, Lu F, Wang L, Wang Y, Xu B, Wang H, Liu S, Liu Z, Chen Y, Miao Q, Su P, Yang Y, Guo S, Lu B, Sun Z, Liu K, Zhang C, Wu Y, Xu H, Zhao W, Han C, Zhou X, Wang E, Huo X, Hu S. No-Touch Versus Conventional Vein Harvesting Techniques at 12 Months After Coronary Artery Bypass Grafting Surgery: Multicenter Randomized, Controlled Trial. Circulation. 2021 Oct 5;144(14):1120-1129. doi: 10.1161/CIRCULATIONAHA.121.055525. Epub 2021 Sep 13.
Results Reference
derived
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No-Touch Versus Conventional Saphenous Vein Harvesting Technique
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