Intra-patient Study With Polymer Free Drug Eluting Stent Versus Abluminal Biodegradable Polymer Drug Eluting Stent With Early OCT (Optical Coherence Tomography) Follow up

NCT ID: NCT02785237

Last Updated: 2019-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2019-01-01

Brief Summary

The objective of the study is to evaluate the process of early re-endothelialization of the Coroflex® ISAR Drug-eluting stent compared with the Ultimaster® Drug-eluting stent

Detailed Description

The objective of the study is to evaluate the process of early re-endothelialization of the Coroflex® ISAR Drug-eluting stent compared with the Ultimaster® Drug-eluting stent

Conditions

Coronary Artery Disease

Study Design

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

Study Groups

Coroflex® ISAR Drug-eluting stent in first lesion

Patients with Coroflex® ISAR Drug-eluting stent in the first lesion

Group Type: ACTIVE_COMPARATOR

Coroflex® ISAR Drug-eluting stent

Intervention Type: DEVICE

Coroflex® ISAR Drug-eluting stent and an Ultimaster® Drug-eluting stent in the second lesion.

Ultimaster® Drug-eluting stent in first lesion

Patients with Ultimaster® Drug-eluting stent in first lesion

Group Type: ACTIVE_COMPARATOR

Ultimaster® Drug-eluting stent

Intervention Type: DEVICE

Ultimaster® Drug-eluting stent and a Coroflex® ISAR Drug-eluting stent in the second lesion.

Coroflex® ISAR Drug-eluting stent in second lesion

Patients with with Ultimaster® Drug-eluting stent in first lesion

Group Type: ACTIVE_COMPARATOR

Coroflex® ISAR Drug-eluting stent

Intervention Type: DEVICE

Coroflex® ISAR Drug-eluting stent and an Ultimaster® Drug-eluting stent in the second lesion.

Ultimaster® Drug-eluting stent in second lesion

Patients with Coroflex® ISAR Drug-eluting stent in the first lesion

Group Type: ACTIVE_COMPARATOR

Ultimaster® Drug-eluting stent

Intervention Type: DEVICE

Ultimaster® Drug-eluting stent and a Coroflex® ISAR Drug-eluting stent in the second lesion.

Interventions

Coroflex® ISAR Drug-eluting stent

Coroflex® ISAR Drug-eluting stent and an Ultimaster® Drug-eluting stent in the second lesion.

Intervention Type: DEVICE

Ultimaster® Drug-eluting stent

Ultimaster® Drug-eluting stent and a Coroflex® ISAR Drug-eluting stent in the second lesion.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Aged ≥ 18 years
• Signature of informed consent
• Patients with angina and a clinical indication for coronary revascularisation with a drug-eluting stent
• Presence of at least 2 lesions to be revascularised with similar angiographic characteristics

• Reference lesion diameter with at most a difference of 0.5 mm
• Maximum difference in lesion length of 10 mm
• Lesions able to be treated with only 1 stent

Exclusion Criteria

• Lesions due to restenosis
• Lesions in saphenous vein grafts
• STE-ACS ( ST elevation- Acute Coronary Syndrome)
• Cardiogenic shock
• Dual antiplatelet therapy contraindication for> 3 months
• Follow-up catheterisation contraindicated

• Chronic kidney failure with creatinine > 2 mg/dL
• Allergy to iodinated contrast agents
• Serious complication from vascular access in previous catheterisation
• Ineligible for evaluation via optical coherence tomography

• Lesion located <5 mm from aorto-ostial junction
• Severe proximal angulation >90º
• Bifurcation lesion requiring a strategy with two stents
• Angiographic characteristics that promote stent malposition

• Aneurysm or coronary artery ectasia
• Presence of a thrombus classed as TIMI (Thrombolysis In Myocardial Infarction )2 flow or higher
• Severe calcification, in particular in cases of calcium spike
• Severe lesion angulation
• Inability to do reliable follow-up, in the investigator's opinion

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

Sponsors

B.Braun Surgical SA

INDUSTRY

Sponsor Role: collaborator

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruno García del Blanco, MD, PhD

Role: STUDY_DIRECTOR

Hospital Universitari Vall d'Hebron (Barcelona)

Locations

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Hospital Clínic de Barcelona

Barcelona, , Spain

Hospital de León

León, , Spain

Countries

Spain

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Other Identifiers

FRIENDLY OCT

Identifier Type: -

Identifier Source: org_study_id