ENdothelial Healing Assessment With Novel Coronary tEchnology

NCT02747199 | Completed DMC

• 1 other identifier: ISROTH10249
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Coronary Artery Disease

Keywords

SYNERGY; Neointimal formation; OCT; coronary angioscopy; coronary artery disease

Outcome Measures

Primary Outcomes (1)

• Apposition and neointimal coverage on the stent and scaffold strut

  Neointimal coverage on the stent and scaffold strut and their apposition using OCT and CAS at 4 month after the stent implantation.

  4 months

Secondary Outcomes (1)

• Apposition and neointimal coverage on the stent and scaffold strut

  12 months

Study Arms (2)

Coronary artery implanted with SYNERGY stent

ACTIVE COMPARATOR

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

Device: SYNERGY stent

Coronary artery implanted with ABSORB scaffold

ACTIVE COMPARATOR

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

Device: BVS ABSORB scaffold

Interventions

SYNERGY stent DEVICE

Coronary artery implanted with SYNERGY stent

BVS ABSORB scaffold DEVICE

Coronary artery implanted with ABSORB scaffold

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Malaya: lead
• Boston Scientific Corporation: collaborator
• Kurume University: collaborator

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Wan Azman Wan Ahmad

  University Malaya Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: April 21, 2016
• Study Start: August 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: April 12, 2017
• Last Updated: May 4, 2017

Record last verified: 2017-05