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Clinical Effect of No-touch Harvesting Technique in OPCABG

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ClinicalTrials.gov Identifier: NCT03729531
Recruitment Status : Recruiting
First Posted : November 2, 2018
Last Update Posted : July 8, 2020
Sponsor:
Collaborator:
Beijing Municipal Administration of Hospitals
Information provided by (Responsible Party):
Zheng Ju-bing, Beijing Anzhen Hospital

Brief Summary:
This study aims to investigate the clinical effect of the new saphenous vein harvesting technique "No-touch" in off-pump coronary artery bypass grafting(OPCABG), comparing to the conventional technique. Adopting CTA to evaluate the 3 months patency of the graft, we will compare veins harvested using No-touch technique to saphenous veins using conventional open technique.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Graft Failure Procedure: Conventional vein harvesting technique Procedure: no-touch vein harvesting technique Not Applicable

Detailed Description:

Coronary artery disease(CAD) is a widespread health issue around the world. It is proven that atherosclerosis is a inflammatory disease, and endothelial dysfunction is one of the key factors that initiates the inflammatory response. Accumulating studies indicate that endothelial homeostasis plays a primordial role in the development of atherosclerosis.

Coronary artery bypass grafting(CABG) is the standard treatment of three-vessel or left main coronary artery disease, and its long-term benefits is apparent. Saphenous vein is the most common graft in CABG, however, the long-term patency is only about 50% in one year, as a result, it is urgent to discover a solution to improve the long term potency of vein grafts.

Conventional harvesting technique dissects the perivascular tissue and inject saline to check leakage, which causes damages to the endothelium of the vein, initiating inflammatory response. No-touch technique is a atraumatic, non-distended harvesting technique. According to the criteria, we will randomize the patients into two groups, the conventional and No-touch group, the vein will be used in sequential anastomosis, by comparing the 3 months patency rate assessed by CTA, we aim to compare the clinical outcomes of the two different vein harvesting techniques.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Clinical Effect of No-touch Vein Harvesting Technique in Off-pump Coronary Artery Bypass Graft
Actual Study Start Date : December 21, 2018
Estimated Primary Completion Date : June 8, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Conventional
The perivascular tissue is stripped off when harvesting the vein, and saline will be used to distend the vein to check for leakage.
Procedure: Conventional vein harvesting technique
Long incision will be used to expose the vein, the perivascular tissue will be dissected carefully by scissors, to check for leakage, the vein will be distended by injecting saline.

Experimental: No-touch
The vein will be harvested by frequency electrotome and the perivascular tissue will be preserved, the vein will not be distended.
Procedure: no-touch vein harvesting technique
The vein will be harvested by low-frequency electrotome, about 5mm surrounding tissue will be preserved with the vein, distention should be avoided, the vein will not be cut off until being anastomosed.




Primary Outcome Measures :
  1. short-term patency rate of vein grafts [ Time Frame: 3 months after surgery ]
    the patency of vein grafts will be assessed by CTA, the doctors of CT department will be masked, at least 2 doctors will provide their conclusions.when the results is controversial, the third doctor will be asked to review the image and provide another conclusion, the patency will be assessed according all results.


Secondary Outcome Measures :
  1. long-term patency rate of vein grafts [ Time Frame: 12 months after surgery ]
    the patency will be assessed by CTA the same as short-term patency

  2. major adverse cardiac and cerebrovascular events(MACCE) rate [ Time Frame: 3 months and 12 months after surgery ]
    all-cause death, myocardial infarction, stroke,repeat revascularizaiton

  3. CCS grade [ Time Frame: 3 months and 12 months after surgery ]
    the grade of angina wii be assessed according to Canadian Cardiovascular Society standard

  4. the healing of the lower leg incision [ Time Frame: 3 months and 12 months after surgery ]
    the healing of the incision will be divided into primary healing, e.g. less tissue defects, neat wound edges, no infection, adhesion or suture to create a tight wound; delayed healing, which means the wound does not closed within 1 month; infection, the wound does not close after 3 months, or necrotic tissues are seen in the incision.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients from northern China
  • first time isolated off-pump coronary artery bypass graft
  • echocardiogram show that ejection fraction is over 35%
  • the diameter of saphenous vein ≥ 2mm
  • the vein graft will be used in sequential anastomosis, and the anastomosis sites ≥2
  • be able to sign informed consent form

Exclusion Criteria:

  • patients who need to undergo urgent surgery
  • Severe renal insufficiency(creatinine >200 umol/L)
  • allergic to radiocontrast agent
  • vein is used to isolated anastomosis
  • Combined with malignant tumor or other severe systemic conditions

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): NCT03729531


Contacts
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Contact: Ju-bing Zheng, M.D. 86-13683113119 zhengjubing@hotmail.com
Contact: Kui Zhang, M.D. 86-15001178663

Locations
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China, Beijing
Beijing Anzhen Hospital, Capital medical university Recruiting
Beijing, Beijing, China, 100029
Contact: Ju-bing Zheng, M.D.         
Sponsors and Collaborators
Beijing Anzhen Hospital
Beijing Municipal Administration of Hospitals
Investigators
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Study Director: Ju-bing Zheng, M.D. Beijing Anzhen Hospital
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Responsible Party: Zheng Ju-bing, Clinical investigator, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier: NCT03729531    
Other Study ID Numbers: PX2018027
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Zheng Ju-bing, Beijing Anzhen Hospital:
Coronary Artery Disease
Coronary Artery Bypass Grafting
Vein Graft Failure
Endothelial dysfunction
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