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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02272582
Other study ID # 003-03
Secondary ID
Status Completed
Phase N/A
First received October 15, 2014
Last updated January 10, 2018
Start date September 24, 2014
Est. completion date December 22, 2016

Study information

Verified date January 2018
Source Montreal Heart Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A prospective randomized, double-blinded, comparative within-person study to evaluate the use of SOMVC001 vs. heparin dosed saline in patients undergoing CABG.


Description:

Saphenous vein (SV) harvesting will be performed using an open or endoscopic vein harvesting technique. Once harvested, the SV will be divided into segments and these vein segments from each patient to be immersed in one of two blinded solutions: SOMVC001 or heparin dosed saline. The patients will then be randomized and SVG segment allocations will be defined and grafted to the assigned target regions. Imaging, using 64-slice or better MDCT, will be completed 4-6 weeks and 3 months post surgery (CABG) procedure.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 22, 2016
Est. primary completion date December 22, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Patient is to undergo primary, multi-vessel CABG with at least two saphenous vein grafts (SVGs)

Exclusion Criteria:

- Patient has in-situ Internal Mammary Artery graft(s) (IMA) only, (no SVG or free arterial grafts)

- Patients has had prior CABG or planned concomitant valve surgery or aortic aneurysm repair.

Study Design


Intervention

Device:
SOMVC001 Vascular Conduit Solution
SV harvesting will be uniformly performed using an open or endoscopic vein harvesting technique. Once harvested, the SV will be divided into segments and these vein segments from each patient to be immersed in one of two blinded solutions: SOMVC001 or heparin dosed saline. The patients will then be randomized and SVG segment allocations will be defined and grafted to the assigned target regions.
Other:
Standard of care Heparin-dosed saline
SV harvesting will be uniformly performed using an open or endoscopic vein harvesting technique. Once harvested, the SV will be divided into segments and these vein segments from each patient to be immersed in one of two blinded solutions: SOMVC001 or heparin dosed saline. The patients will then be randomized and SVG segment allocations will be defined and grafted to the assigned target regions.

Locations

Country Name City State
Canada Montreal Heart Institute Montreal Quebec

Sponsors (3)

Lead Sponsor Collaborator
Perrault Louis P. Montreal Heart Institute, Somahlution LLC

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean wall thickness of paired grafts within 100 participants measured at 4-6 weeks and 3 months post-CABG surgery using 64-slice multidetector computed tomography (MDCT) angiography. 4-6 weeks to 3 months
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