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Clinical Effect of No-touch Harvesting Technique in OPCABG

Primary Purpose

Coronary Artery Disease, Graft Failure

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Conventional vein harvesting technique
no-touch vein harvesting technique
Sponsored by
Beijing Anzhen Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, Coronary Artery Bypass Grafting, Vein Graft Failure, Endothelial dysfunction

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Anzhen Hospital, Capital medical universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional

No-touch

Arm Description

The perivascular tissue is stripped off when harvesting the vein, and saline will be used to distend the vein to check for leakage.

The vein will be harvested by frequency electrotome and the perivascular tissue will be preserved, the vein will not be distended.

Outcomes

Primary Outcome Measures

short-term patency rate of vein grafts
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

long-term patency rate of vein grafts
the patency will be assessed by CTA the same as short-term patency
major adverse cardiac and cerebrovascular events(MACCE) rate
all-cause death, myocardial infarction, stroke,repeat revascularizaiton
CCS grade
the grade of angina wii be assessed according to Canadian Cardiovascular Society standard
the healing of the lower leg incision
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.

Full Information

First Posted
November 1, 2018
Last Updated
July 6, 2020
Sponsor
Beijing Anzhen Hospital
Collaborators
Beijing Municipal Administration of Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT03729531
Brief Title
Clinical Effect of No-touch Harvesting Technique in OPCABG
Official Title
The Clinical Effect of No-touch Vein Harvesting Technique in Off-pump Coronary Artery Bypass Graft
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 21, 2018 (Actual)
Primary Completion Date
June 8, 2021 (Anticipated)
Study Completion Date
July 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Anzhen Hospital
Collaborators
Beijing Municipal Administration of Hospitals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Graft Failure
Keywords
Coronary Artery Disease, Coronary Artery Bypass Grafting, Vein Graft Failure, Endothelial dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional
Arm Type
Active Comparator
Arm Description
The perivascular tissue is stripped off when harvesting the vein, and saline will be used to distend the vein to check for leakage.
Arm Title
No-touch
Arm Type
Experimental
Arm Description
The vein will be harvested by frequency electrotome and the perivascular tissue will be preserved, the vein will not be distended.
Intervention Type
Procedure
Intervention Name(s)
Conventional vein harvesting technique
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
no-touch vein harvesting technique
Intervention Description
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 Measure Information:
Title
short-term patency rate of vein grafts
Description
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.
Time Frame
3 months after surgery
Secondary Outcome Measure Information:
Title
long-term patency rate of vein grafts
Description
the patency will be assessed by CTA the same as short-term patency
Time Frame
12 months after surgery
Title
major adverse cardiac and cerebrovascular events(MACCE) rate
Description
all-cause death, myocardial infarction, stroke,repeat revascularizaiton
Time Frame
3 months and 12 months after surgery
Title
CCS grade
Description
the grade of angina wii be assessed according to Canadian Cardiovascular Society standard
Time Frame
3 months and 12 months after surgery
Title
the healing of the lower leg incision
Description
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.
Time Frame
3 months and 12 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ju-bing Zheng, M.D.
Phone
86-13683113119
Email
zhengjubing@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kui Zhang, M.D.
Phone
86-15001178663
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ju-bing Zheng, M.D.
Organizational Affiliation
Beijing Anzhen Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Anzhen Hospital, Capital medical university
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ju-bing Zheng, M.D.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Clinical Effect of No-touch Harvesting Technique in OPCABG

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