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

NCT02785237 | Completed DMC

• 1 other identifier: FRIENDLY OCT
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 3

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

Conditions

Coronary Artery Disease

Keywords

Drug-eluting stent; OCT; Re-endothelialization

Outcome Measures

Primary Outcomes (5)

• Percentage of early coating on the struts of the Coroflex® ISAR Drug-eluting stent versus Ultimaster® - Drug eluting stent at 3 months OCT after stent implantation.

  3 months

• Percentage of covered struts at 3 months OCT after stent implantation.

  3 months

• Percentage of stents with ≥3% of uncovered struts at 3 months OCT after stent implantation.

  3 months

• Percentage of uncovered struts ≥3% at 3 months OCT after stent implantation.

  3 months

• Number of transversal sections with a percentage (rate of uncovered struts/ total number of struts) > 30 % at 3 months OCT after stent implantation.

  3 months

Secondary Outcomes (10)

• Percentage of covered struts, at 1 month, 2 months and 3 months OCT after stent implantation.

  1 month and 2 months and 3 months

• Total Tissue coverage at 1month, 2 months and 3 months OCT after stent implantation.

  1 month and 2 months and 3 months

• Mean thickness of struts tissue coverage at 1 month, 2 months and 3 months OCT after stent implantation.

  1 month and 2 months and 3 months

• MACE (Major Adverse Cardiac Events) at 30 days, 3 months, 6 months and 12 months.

  30 days and 3 months and 6 months and 12 months

• Target lesion revascularization and target vessel revascularization at 30 days, 3 months, 6 months and 12 months OCT after stent implantation .

  30 days and 3 months and 6 months and 12 months

Study Arms (4)

Coroflex® ISAR Drug-eluting stent in first lesion

ACTIVE COMPARATOR

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

Device: Coroflex® ISAR Drug-eluting stent

Ultimaster® Drug-eluting stent in first lesion

ACTIVE COMPARATOR

Patients with Ultimaster® Drug-eluting stent in first lesion

Device: Ultimaster® Drug-eluting stent

Coroflex® ISAR Drug-eluting stent in second lesion

ACTIVE COMPARATOR

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

Device: Coroflex® ISAR Drug-eluting stent

Ultimaster® Drug-eluting stent in second lesion

ACTIVE COMPARATOR

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

Device: Ultimaster® Drug-eluting stent

Interventions

Coroflex® ISAR Drug-eluting stent DEVICE

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

Coroflex® ISAR Drug-eluting stent in first lesion; Coroflex® ISAR Drug-eluting stent in second lesion

Ultimaster® Drug-eluting stent DEVICE

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

Ultimaster® Drug-eluting stent in first lesion; Ultimaster® Drug-eluting stent in second lesion

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead
• B.Braun Surgical SA: collaborator

Study Sites (3)

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

Hospital de León

León, 24008, Spain

Location

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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

• Bruno García del Blanco, MD, PhD

  Hospital Universitari Vall d'Hebron (Barcelona)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2016
• First Posted: May 27, 2016
• Study Start: June 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: January 3, 2019

Record last verified: 2019-01

Locations

ES (3)