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

January 2, 2019 updated by: Hospital Universitari Vall d'Hebron Research Institute

Intra-patient Randomized Study With Polymer Free Drug Eluting Stent Versus Abluminal Biodegradable Polymer Drug Eluting Stent With Early OCT Follow up

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clínic de Barcelona
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • León, Spain, 24008
        • Hospital de León

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Coroflex® ISAR Drug-eluting stent in first lesion
Patients with Coroflex® ISAR Drug-eluting stent in the first lesion
Device: Coroflex® ISAR Drug-eluting stent
Coroflex® ISAR Drug-eluting stent and an Ultimaster® Drug-eluting stent in the second lesion.
Active Comparator: Ultimaster® Drug-eluting stent in first lesion
Patients with Ultimaster® Drug-eluting stent in first lesion
Device: Ultimaster® Drug-eluting stent
Ultimaster® Drug-eluting stent and a Coroflex® ISAR Drug-eluting stent in the second lesion.
Active Comparator: Coroflex® ISAR Drug-eluting stent in second lesion
Patients with with Ultimaster® Drug-eluting stent in first lesion
Device: Coroflex® ISAR Drug-eluting stent
Coroflex® ISAR Drug-eluting stent and an Ultimaster® Drug-eluting stent in the second lesion.
Active Comparator: Ultimaster® Drug-eluting stent in second lesion
Patients with Coroflex® ISAR Drug-eluting stent in the first lesion
Device: Ultimaster® Drug-eluting stent
Ultimaster® Drug-eluting stent and a Coroflex® ISAR Drug-eluting stent in the second lesion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 3 months
3 months
Percentage of covered struts at 3 months OCT after stent implantation.
Time Frame: 3 months
3 months
Percentage of stents with ≥3% of uncovered struts at 3 months OCT after stent implantation.
Time Frame: 3 months
3 months
Percentage of uncovered struts ≥3% at 3 months OCT after stent implantation.
Time Frame: 3 months
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.
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of covered struts, at 1 month, 2 months and 3 months OCT after stent implantation.
Time Frame: 1 month and 2 months and 3 months
1 month and 2 months and 3 months
Total Tissue coverage at 1month, 2 months and 3 months OCT after stent implantation.
Time Frame: 1 month and 2 months and 3 months
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.
Time Frame: 1 month and 2 months and 3 months
1 month and 2 months and 3 months
MACE (Major Adverse Cardiac Events) at 30 days, 3 months, 6 months and 12 months.
Time Frame: 30 days and 3 months and 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 .
Time Frame: 30 days and 3 months and 6 months and 12 months
30 days and 3 months and 6 months and 12 months
Percentage of stent malapposition at 1 month and 3 months OCT after stent implantation.
Time Frame: 1 month and 2 months and 3 months
1 month and 2 months and 3 months
Percentage of struts malapposition at 1 month and 3 months OCT after stent implantation.
Time Frame: 1 month and 2 months and 3 months
1 month and 2 months and 3 months
Percentage of struts malapposition> 260 µm at 1 month and 3 months OCT after stent implantation.
Time Frame: 1 month and 2 months and 3 months
1 month and 2 months and 3 months
Percentage of stents with any malapposition strut > 260 µm at 1 month and 3 months OCT after stent implantation.
Time Frame: 1 month and 2 months and 3 months
1 month and 2 months and 3 months
Healing Score at 1 month and 3 months OCT after stent implantation .
Time Frame: 1 month and 2 months and 3 months
1 month and 2 months and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Collaborators

B.Braun Surgical SA

Investigators

  • Study Director: Bruno García del Blanco, MD, PhD, Hospital Universitari Vall d'Hebron (Barcelona)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

May 20, 2016

First Submitted That Met QC Criteria

May 26, 2016

First Posted (Estimate)

May 27, 2016

Study Record Updates

Last Update Posted (Actual)

January 3, 2019

Last Update Submitted That Met QC Criteria

January 2, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FRIENDLY OCT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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