The eMESH 1 Feasibility Study
This study is currently recruiting participants.
Verified February 2013 by Kips Bay Medical, Inc.
Sponsor:
Kips Bay Medical, Inc.
Information provided by (Responsible Party):
Kips Bay Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01676376
First received: August 21, 2012
Last updated: February 19, 2013
Last verified: February 2013
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Purpose
Multi-center, randomized 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. Each study subject will receive a SVG without Mesh (control) and a SVG with Mesh (treatment). The subject will be used as their own control.
| Condition | Intervention | Phase |
|---|---|---|
|
Atherosclerosis of Autologous Vein Coronary Artery Bypass Graft(s) |
Device: eSVS Mesh treated saphenous vein graft Other: Control saphenous vein graft |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multi-center, Randomized Study of External Saphenous Vein Support Using eSVS® Mesh in CABG Surgery: The eMESH I Study |
Resource links provided by NLM:
Further study details as provided by Kips Bay Medical, Inc.:
Primary Outcome Measures:
- MACE [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]The rate of major adverse coronary events (MACE) defined as the rate of the composite of total mortality, MI (Q wave and non Q wave), and/or coronary target vessel revascularization (percutaneous coronary intervention or CABG).
- SVG patency determined by angiography [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Angiographic patency rate of the enrolled grafts defined as < 50% stenosis.
- Technical success implanting eSVS Mesh [ Time Frame: intra-operative ] [ Designated as safety issue: No ]Technical success defined as successful placement of the eSVS Mesh on the saphenous vein and surgical implantation of the SVG.
Secondary Outcome Measures:
- MACCE and mediastinitis [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]MACE, MACCE, MI and all mortality rates through five years, mediastinitis rate through 6 months.
- SVG patency determined by angiography [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Angiographic patency rate of the enrolled grafts defined as < 75%.
- Plaque burden [ Time Frame: 6 months ] [ Designated as safety issue: No ]Plaque burden of the enrolled grafts as assessed by IVUS imaging (IVUS Sub-Study).
| Estimated Enrollment: | 120 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | December 2018 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Device: 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.
|
|
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.
|
Other: 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.
|
Eligibility| Ages Eligible for Study: | 21 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
- 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 > 80 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.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01676376
Contacts
| Contact: Rebecca Wetterling | 763-235-3540 | clinical@kipsbaymedical.com |
Locations
| United States, Georgia | |
| Northeast Georgia Heart Center | Recruiting |
| Gainesville, Georgia, United States, 30501 | |
| Principal Investigator: Alan Wolfe, MD | |
| France | |
| C.H.U. Dupuytren | Recruiting |
| Limoges, France | |
| Principal Investigator: Marc Laskar, MD | |
| Bordeaux University Hospital | Recruiting |
| Pessac, France | |
| Principal Investigator: Louis Labrousse, Prof. Dr. | |
| Italy | |
| Heart Hospital - G. Monasterio Tuscany Foundation for Health & Research | Not yet recruiting |
| Massa, Italy | |
| Principal Investigator: Mattias Glauber, Dr. | |
| Switzerland | |
| University Hospital of Bern | Recruiting |
| Bern, Switzerland, 3010 | |
| Principal Investigator: Lars Englberger, Dr. | |
Sponsors and Collaborators
Kips Bay Medical, Inc.
Investigators
| Principal Investigator: | Lars Englberger, MD | University of Bern |
| Principal Investigator: | John Puskas, MD | Emory University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Kips Bay Medical, Inc. |
| ClinicalTrials.gov Identifier: | NCT01676376 History of Changes |
| Other Study ID Numbers: | 11016 |
| Study First Received: | August 21, 2012 |
| Last Updated: | February 19, 2013 |
| Health Authority: | Switzerland: Swissmedic United States: Food and Drug Administration Germany: Ethics Commission France: Institutional Ethical Committee Italy: Ethics Committee |
Keywords provided by Kips Bay Medical, Inc.:
|
CABG SVG nitinol mesh external saphenous vein graft support |
Additional relevant MeSH terms:
|
Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013