Recruiting
Phase 1
Phase 2

Observational Study

Sponsor:

Kips Bay Medical, Inc.

Code:

NCT01676376

Conditions

Atherosclerosis of Autologous Vein Coronary Artery Bypass Graft(s)

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

eSVS Mesh treated saphenous vein graft

Control saphenous vein graft

Study Details

Brief summary:

Multi-center, dual cohort (randomized and single vessel) study designed to demonstrate feasibility, initial safety and performance of the Kips Bay Medical, Inc. eSVS® Mesh as an external vein support device for use over saphenous vein grafts during coronary artery bypass surgery. In the Randomized Cohort, each study subject will receive a SVG without Mesh (control) and a SVG with the eSVS Mesh (treatment). In the Single Vessel Cohort, each study subject will receive one SVG with the eSVS Mesh.

Conditions

Atherosclerosis of Autologous Vein Coronary Artery Bypass Graft(s)

Study ID

NCT01676376

Start date

Aug, 2012

Status verified date

Feb, 2015

Completion date

Jun, 2020

Anticipated

Primary completion date

Dec, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Randomized Cohort: Requires CABG surgery with a SVG to the right coronary artery (RCA) system AND the left circumflex artery (LCX) system with a ≥ 70% stenosis in each of the two systems.
  • Single Vessel Cohort: Requires CABG surgery with a SVG to the RCA system or the LCX system with a > 70% stenosis in the system.
  • Medial sternotomy with cardiopulmonary bypass (CPB) during surgery.
  • Both saphenous vein graft length are adequate for planned intervention, vein outer diameter is between 3.6 mm and 7.0 mm and double wall thickness less than 1.4 mm.
  • Agreement to post-procedure follow-up contact and testing (including follow-up coronary angiogram).

Exclusion Criteria:

  • Concomitant non-CABG cardiac procedure.
  • Prior cardiac surgery (does not include percutaneous procedures).
  • Cerebrovascular or transient ischemia attack within 30 days of the CABG procedure.
  • Age > 85 years.
  • Left ventricular ejection fraction ≤ 35%.
  • Creatinine > 133 μmol/L (1.5 mg/dL) prior to CABG procedure or on chronic dialysis.
  • STEMI within 7 days or total CK > 2 times the upper limit of normal prior to the CABG procedure.
  • Both enrolled grafts will feed non-viable myocardial territory.
  • Diffuse atherosclerotic disease (> 70%) distal to either of the enrolled target coronary arteries.
  • Randomized Cohort: By visual estimate, the target coronary artery diameter of both the right coronary system and left circumflex system must be within 1.5mm of each other.
  • Planned endarterectomy of the target coronary artery.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: eSVS Mesh treated saphenous vein graft

Each subject will be randomized to an eSVS Mesh treated SVG to the right or left coronary system.

sham comparator: Control saphenous vein graft

Each subject will be randomized to an untreated (no eSVS Mesh) SVG to the right or left coronary system.

active comparator: Single Vessel Treatment

Each subject with receive one SVG with eSVS Mesh either to the right or left coronary system.

Interventions

eSVS Mesh treated saphenous vein graft

During coronary artery bypass graft surgery, one SVG will be randomized to be treated with eSVS Mesh and implanted in the right or left coronary system.

Control saphenous vein graft

During coronary artery bypass graft surgery, one SVG will be randomized to be the control (no eSVS Mesh) and implanted in the right or left coronary system.

Primary outcome measure

  • MACE [ Time Frame: 30 days ]
  • SVG patency determined by angiography [ Time Frame: 6 months ]
  • Technical success implanting eSVS Mesh [ Time Frame: intra-operative ]

Central Contacts and Locations

Central contacts

Rebecca Wetterling

763-235-3540clinical@kipsbaymedical.com

Locations

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Principal Investigator:

Omar Lattouf, MD

Northeast Georgia Heart Center

Recruiting

Gainesville, Georgia, United States, 30501

Principal Investigator:

Alan Wolfe, MD

Mayo Clinic / St. Mary's Hospital

Recruiting

Rochester, Minnesota, United States, 55905

Principal Investigator:

Lyle Joyce, MD

The Valley Hospital

Recruiting

Ridgewood, New Jersey, United States, 07450

Contacts

Kimberly Michel, RN

201-447-8000

Principal Investigator:

Juan Grau, MD

Lenox Hill Hospital

Recruiting

New York, New York, United States, 10075

Principal Investigator:

Nirav Patel, MD

More Information

Sponsor

Kips Bay Medical, Inc.

Last update posted

Feb 19, 2015

Last verified

Feb, 2015

Keywords

  • CABG
  • SVG
  • nitinol mesh
  • external saphenous vein graft support

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kips Bay Medical, Inc. on 2015-02-19.