Vessel Injury in Relation With Strut Thickness Assessed by OCT

NCT ID: NCT03026465

Last Updated: 2019-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-16
• Study Completion Date: 2018-07-27

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Coroflex ISAR 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.

Group Type: EXPERIMENTAL

Polymer-free stent

Intervention Type: DEVICE

PCI using a polymer-free dual-drug sirolimus- and probucol-eluting stent (Coroflex ISAR)

Biomatrix 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.

Group Type: ACTIVE_COMPARATOR

Biodegradable-polymer stent

Intervention Type: DEVICE

PCI using a biodegradable-polymer biolimus-eluting stent (Biomatrix)

Interventions

Polymer-free stent

PCI using a polymer-free dual-drug sirolimus- and probucol-eluting stent (Coroflex ISAR)

Intervention Type: DEVICE

Biodegradable-polymer stent

PCI using a biodegradable-polymer biolimus-eluting stent (Biomatrix)

Intervention Type: DEVICE

Other Intervention Names

Coroflex ISAR; Biomatrix

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

B.Braun Surgical SA

INDUSTRY

Sponsor Role: collaborator

Fundacion Investigacion Interhospitalaria Cardiovascular

OTHER

Sponsor Role: lead

Responsible Party

Nieves Gonzalo

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nieves Gonzalo, MD, PhD

Role: STUDY_DIRECTOR

Hospital Clinico San Carlos de Madrid

Locations

Complejo Hospitalario Universitario de Vigo

Vigo, Pontevedra, Spain

Hospital Clinico San Carlos

Madrid, , Spain

Hospital Universitario de La Princesa

Madrid, , Spain

Countries

Spain

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Other Identifiers

VISTA

Identifier Type: -

Identifier Source: org_study_id