ENdothelial Healing Assessment With Novel Coronary tEchnology

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

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2017-04-12

Brief Summary

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

This is a prospective, non-randomized, single center clinical trial to assess neointimal coverage on the stent or scaffold strut and apposition of SYNERGY™ and ABSORB in minimum of 12 eligible human subject at 4 month and 12 month after stent or scaffold implantation using OCT and CAS

Related Clinical Trials

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

Strut Coverage With SYNERGY Stents and Bioresorbable Vascular Scaffold in Acute Myocardial Infarction

NCT02890589

Acute Coronary Syndrome

COMPLETED NA

StEnt Coverage and Neointimal Tissue Characterization After eXtra Long evErolimus - Eluting Stent imPlantation

NCT03401216

Ischemic Heart Disease Coronary Artery Disease Coronary Atherosclerosis

UNKNOWN NA

A Clinical Evaluation of Absorb™ Bioresorbable Vascular Scaffold (Absorb™ BVS) System in Chinese Population ~ ABSORB CHINA Randomized Controlled Trial (RCT)

NCT01923740

Coronary Artery Disease Coronary Artery Stenosis Coronary Disease +1 more

COMPLETED NA

A Post-Approval, Single-Arm Study of the SYNERGY Stent System in China

NCT03736226

Cardiovascular Diseases

ACTIVE_NOT_RECRUITING

OCT Based Edge and In-stent Vascular Response After Cordimax Stent in patIents With NSTE-ACS

NCT02868203

Angina, Unstable Non-ST-Segment Elevation Myocardial Infarction

UNKNOWN PHASE4

Detailed Description

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

All of the subject will received SYNERGY™ stent in one of the blocked coronary artery and ABSORB scaffold strut in the other artery. All subjects must have 2 coronary arteries stenosis of more than 70%.

Conditions

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

Coronary Artery Disease

Study Design

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

Allocation Method

NON_RANDOMIZED

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.

Coronary artery implanted with SYNERGY stent

One of the blocked coronary artery of a patient will received SYNERGY stent

Group Type ACTIVE_COMPARATOR

SYNERGY stent

Intervention Type DEVICE

Coronary artery implanted with ABSORB scaffold

Another blocked coronary artery of the same patient will received ABSORB scaffold

Group Type ACTIVE_COMPARATOR

BVS ABSORB scaffold

Intervention Type DEVICE

Interventions

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

SYNERGY stent

Intervention Type DEVICE

BVS ABSORB scaffold

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. Subject is 20 years old or older
2. Subject or legally authorized representative must provide written informed consent prior to any study related procedure, per site requirements.
3. Subject must have evidence of myocardial ischemia (eg stable or unstable angina, silent ischemia) suitable for elective PCI
4. Significant narrowing of at least 70% stenosis of de novo lesion (QCA or visual estimation) in 2 different native coronary arteries.
5. Subject is eligible for to undergo OCT and CAS examination at 4 months and 12 months after stent or scaffold implantation.
6. Subject is able to take dual anti-platelet therapy up to one year following the index procedure and anticoagulants prior/during the index procedure

Exclusion Criteria

1. Subject had an acute myocardial infarction (STEMI or NSTEMI) within 24 hours of the index procedure
2. Subject has known left ventricular ejection fraction (LVEF) \< 30%
3. Subject is receiving hemodialysis
4. Target vessel were treated by PCI within 12 months
5. Target lesion is located within a saphenous vein graft or an arterial graft
6. Target lesion is located in ostium
7. Target lesion is located highly tortuous equal to or greater than 60 degrees
8. Target lesion with TIMI flow 0 (total occlusion)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No