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No-Touch Versus Conventional Saphenous Vein Harvesting Technique

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03126409
Recruitment Status : Unknown
Verified October 2019 by China National Center for Cardiovascular Diseases.
Recruitment status was:  Active, not recruiting
First Posted : April 24, 2017
Last Update Posted : July 14, 2020
Sponsor:
Information provided by (Responsible Party):
China National Center for Cardiovascular Diseases

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Procedure: No-Touch vein harvesting technique Procedure: Conventional vein harvesting Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2655 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : May 14, 2017
Actual Primary Completion Date : September 30, 2019
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: No-Touch vein harvesting technique
During saphenous vein harvesting, surrounding tissue of the vein is preserved, and manual distension of the vein graft is avoided
Procedure: No-Touch vein harvesting technique
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.

Active Comparator: Conventional vein harvesting
During saphenous vein harvesting, surrounding tissue of the vein is stripped off, and manual distension is routinely performed
Procedure: Conventional vein harvesting
During saphenous vein harvesting, surrounding tissue of the vein is stripped off, and manual distension is routinely performed




Primary Outcome Measures :
  1. Prevalence of graft occlusion [ Time Frame: 3 month after procedure ]
    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 :
  1. Prevalence of graft occlusion [ Time Frame: 1 year after procedure ]
    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.

  2. Overall major adverse cardiac or cerebrovascular events (MACCE) rate [ Time Frame: 3 month and 1 year after procedure ]
    MACCE includes death, myocardial infarction, stroke and/or repeat revascularization

  3. Cardiac death [ Time Frame: 3 month and 1 year after procedure ]
    death from any heart disease

  4. Documented non-lethal myocardial infarction [ Time Frame: 3 month and 1 year after procedure ]
    Myocardial infarction is defined according to the most recent guideline

  5. Stroke [ Time Frame: 3 month and 1 year after procedure ]
    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

  6. Target lesion revascularization [ Time Frame: 3 month and 1 year after procedure ]
    CABG or percutaneous coronary intervention

  7. Recurrence of Angina [ Time Frame: 3 month and 1 year after procedure ]
    recurrence of unstable angina



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03126409


Locations
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China, Beijing
Fuwai Hospital Chinese Academay of Medical Science and National Center for Cardiovascular Diseases
Beijing, Beijing, China, 100037
Sponsors and Collaborators
China National Center for Cardiovascular Diseases
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier: NCT03126409    
Other Study ID Numbers: 20170414
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by China National Center for Cardiovascular Diseases:
coronary artery disease
coronary artery bypass graft
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases