NCT03729531

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

December 21, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2021

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

July 8, 2020

Status Verified

July 1, 2020

Enrollment Period

2.5 years

First QC Date

November 1, 2018

Last Update Submit

July 6, 2020

Conditions

Coronary Artery DiseaseGraft Failure

Keywords

Coronary Artery DiseaseCoronary Artery Bypass GraftingVein Graft FailureEndothelial dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months after surgery

Secondary Outcomes (4)

  • long-term patency rate of vein grafts

    12 months after surgery

  • major adverse cardiac and cerebrovascular events(MACCE) rate

    3 months and 12 months after surgery

  • CCS grade

    3 months and 12 months after surgery

  • the healing of the lower leg incision

    3 months and 12 months after surgery

Study Arms (2)

Conventional

ACTIVE COMPARATOR

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

No-touch

EXPERIMENTAL

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

Interventions

Conventional vein harvesting techniquePROCEDURE

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.

Conventional
no-touch vein harvesting techniquePROCEDURE

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.

No-touch

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anzhen Hospital, Capital medical university

Beijing, Beijing Municipality, 100029, China

RECRUITING

Related Publications (1)

  • Peng Z, Zhao R, Yang Y, Hua K, Yang X. Predictive Value of the CT-Based Visceral Adiposity Tissue Index and Triglyceride-Glucose Index on New-Onset Atrial Fibrillation after Off-Pump Coronary Artery Bypass Graft: Analyses from a Longitudinal Study. Rev Cardiovasc Med. 2023 Nov 30;24(11):338. doi: 10.31083/j.rcm2411338. eCollection 2023 Nov.

    PMID: 39076438DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Ju-bing Zheng, M.D.

    Beijing Anzhen Hospital

    STUDY DIRECTOR

Central Study Contacts

Ju-bing Zheng, M.D.

CONTACT

86-13683113119zhengjubing@hotmail.com

Kui Zhang, M.D.

CONTACT

86-15001178663

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical investigator

Study Record Dates

First Submitted

November 1, 2018

First Posted

November 2, 2018

Study Start

December 21, 2018

Primary Completion

June 8, 2021

Study Completion

July 1, 2021

Last Updated

July 8, 2020

Record last verified: 2020-07

Locations

CN(1)