The eMESH 1 Feasibility Study
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: I/II What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 12-009450
NCT ID: NCT01676376
Sponsor Protocol Number: PRO-11016
About this study
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.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility 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)
- 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
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.