CD0104 VEST II Post Marketing Surveillance Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is designed to collect post market data on use of the VEST, particularly on saphenous vein grafts to the right territory of the heart.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

VEST Device to Enhance Safein Vein Patency

NCT06500897

Coronary Artery Bypass

COMPLETED

In-Stent Restenosis Post-Approval Study

NCT02542267

Peripheral Artery Disease Vascular Disease

COMPLETED NA

The VIRTUE Post Marketing Surveillance Registry

NCT01213589

Aortic Dissection

COMPLETED

Evaluation of the GTX™ 5126 DES Coronary Stent System in the Treatment of Patients With a Lesion in the Coronary Artery

NCT00777842

Coronary Artery Disease

TERMINATED NA

Evaluation of the Valiant Captivia Physician Fenestrated Stent Graft System in Aortic Arch and Descending Thoracic Aorta Pathologies

NCT05479305

Penetrating Ulcer of Aorta Aneurysm Aortic Type B Aortic Dissection +1 more

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The primary objective is to test the early-mid term patency rate of VEST supported Right Coronary Artery (RCA) bypass grafts. The research participants will undergo CABG preparations and CABG procedure routinely as is the standard of care. During the procedure the VEST will be implanted on the vein graft to the Right Coronary Artery according to the IFU. Perioperative care is according to standard of care. Upon discharge patient will be prescribed statins and aspirin for 6 months. Patient will attend a routine clinic visit 4-6 weeks post operatively. The last study visit will occur 3-6 months post operatively. Patients will undergo a noninvasive coronary CT angiography.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Bypass Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

VEST

Group Type EXPERIMENTAL

VEST

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

VEST

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patient scheduled for on-pump CABG on clinical grounds
2. At least one vein graft bypass indicated for right coronary artery and LIMA indicated for the LAD on clinical grounds
3. Appropriately sized and accessible target coronary arteries, with a minimum diameter of 1.5 mm and adequate vascular bed, as assessed from the pre-operative cardiac angiography.

Exclusion Criteria

1. Concomitant non-CABG cardiac procedure
2. Prior cardiac surgery
3. Emergency CABG surgery (cardiogenic shock, inotropic pressure support, IABP)
4. Contraindication for on-pump CABG with cardioplegic arrest (e.g. severely calcified aorta)
5. Calcification at the intended anastomotic sites, as assessed upon opening of the chest and before VEST implantation.
6. Prior debilitating stroke less than 1 year before surgery
7. Severe renal dysfunction (Cr\>2.0 mg/dL)
8. Concomitant life-threatening disease likely to limit life expectancy to less than 2 years.

Eligible Sex

ALL

Accepts Healthy Volunteers

No