Vessel Injury in Relation With Strut Thickness Assessed by OCT

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Polymer-free stent; Device: Biodegradable-polymer stent

• Registration Number: NCT03026465
• Lead Sponsor: Fundacion Investigacion Interhospitalaria Cardiovascular

Brief Summary

The objective of the present study is to determine the relation between vascular injury induced by the stent and strut thickness.

Detailed Description

Thinner struts produce less arterial injury after stent implantation.The objective of the present study is to determine the relation between vascular injury induced by the stent and strut thickness. Vessel injury after stent implantation will be evaluated with optical coherence tomography (OCT). Two stents platforms with different strut thickness (Coroflex ISAR 50 microns and Biomatrix 120 microns) will be compared.

Study Timeline

• Study First Submitted: 2016-10-28
• Study First Submitted QC: 2017-01-17
• Study First Posted: 2017-01-20
• Study Start: 2017-02-16
• Primary Completion: 2018-07-27
• Study Completion: 2018-07-27
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-20
• Last Update Posted: 2019-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients older than 18 years
• Ischemic symptoms or evidence of myocardial ischemia (inducible or spontaneous) in the presence of >50% de novo stenosis located in native coronary vessels

Exclusion Criteria

• Target lesion located in the left main stem
• STEMI
• Restenosis
• Cardiogenic shock
• Malignancies or other comorbid conditions with life expectancy less than 12 months or that may result in protocol noncompliance
• Known allergy to the study medications (probucol, sirolimus, zotarolimus)
• Pregnancy (present, suspected, or planned)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coroflex ISAR stent	Polymer-free stent	PCI with a polymer-free dual-drug sirolimus- and probucol-eluting stent (Coroflex ISAR stent) with very thin struts (50 µm). During the PCI, an OCT assessment (baseline and post-implantation) will be performed.
Biomatrix stent	Biodegradable-polymer stent	PCI with a biodegradable-polymer biolimus-eluting stent (Biomatrix stent) with 120 µm struts. During the PCI, an OCT assessment (baseline and post-implantation) will be performed.

Primary Outcome Measures

Name	Time	Method
OCT-based intimal injury score	Up to 1 day (evaluated after stent implantation)	OCT-based intimal injury score estimated after implantation of the Coroflex-ISAR and Biomatrix DES

Secondary Outcome Measures

Name	Time	Method
Incidence of stent malapposition	Up to 1 day (evaluated after stent implantation)	Stent apposition after implantation of Coroflex-ISAR and Biomatrix as assessed by OCT
Incidence of stent underexpansion	Up to 1 day (evaluated after stent implantation)	Stent expansion will be measured with OCT after implantation of Coroflex-ISAR and Biomatrix
Tissue prolapse area	Up to 1 day (evaluated after stent implantation)	Tissue prolapse area assessed by OCT after implantation of Coroflex-ISAR and Biomatrix will be measured
Stent symmetry after implantation	Up to 1 day (evaluated after stent implantation)	Stent symmetry will be measured with OCT after implantation of Coroflex-ISAR and Biomatrix
Baseline plaque type	Up to 1 day (evaluated after stent implantation)	Baseline plaque type will be assessed by OCT (fibrous, fibrocalcific or lipid-rich)

Trial Locations

Locations (3)

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain

Complejo Hospitalario Universitario de Vigo; 🇪🇸 Vigo, Pontevedra, Spain

Hospital Universitario de La Princesa; 🇪🇸 Madrid, Spain