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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Coroflex® ISAR Drug-eluting stent
Ultimaster® Drug-eluting stent
Sponsored by
Hospital Universitari Vall d'Hebron Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Drug-eluting stent, OCT, Re-endothelialization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitari Vall d'Hebron
  • Hospital Clínic de Barcelona
  • Hospital de León

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Coroflex® ISAR Drug-eluting stent in first lesion

Ultimaster® Drug-eluting stent in first lesion

Coroflex® ISAR Drug-eluting stent in second lesion

Ultimaster® Drug-eluting stent in second lesion

Arm Description

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

Patients with Ultimaster® Drug-eluting stent in first lesion

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of covered struts, at 1 month, 2 months and 3 months OCT after stent implantation.
Total Tissue coverage at 1month, 2 months and 3 months OCT after stent implantation.
Mean thickness of struts tissue coverage at 1 month, 2 months and 3 months OCT after stent implantation.
MACE (Major Adverse Cardiac Events) at 30 days, 3 months, 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 .
Percentage of stent malapposition at 1 month and 3 months OCT after stent implantation.
Percentage of struts malapposition at 1 month and 3 months OCT after stent implantation.
Percentage of struts malapposition> 260 µm at 1 month and 3 months OCT after stent implantation.
Percentage of stents with any malapposition strut > 260 µm at 1 month and 3 months OCT after stent implantation.
Healing Score at 1 month and 3 months OCT after stent implantation .

Full Information

First Posted
May 20, 2016
Last Updated
January 2, 2019
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Collaborators
B.Braun Surgical SA
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1. Study Identification

Unique Protocol Identification Number
NCT02785237
Brief Title
Intra-patient Study With Polymer Free Drug Eluting Stent Versus Abluminal Biodegradable Polymer Drug Eluting Stent With Early OCT (Optical Coherence Tomography) Follow up
Official Title
Intra-patient Randomized Study With Polymer Free Drug Eluting Stent Versus Abluminal Biodegradable Polymer Drug Eluting Stent With Early OCT Follow up
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
January 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Collaborators
B.Braun Surgical SA

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Drug-eluting stent, OCT, Re-endothelialization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Coroflex® ISAR Drug-eluting stent in first lesion
Arm Type
Active Comparator
Arm Description
Patients with Coroflex® ISAR Drug-eluting stent in the first lesion
Arm Title
Ultimaster® Drug-eluting stent in first lesion
Arm Type
Active Comparator
Arm Description
Patients with Ultimaster® Drug-eluting stent in first lesion
Arm Title
Coroflex® ISAR Drug-eluting stent in second lesion
Arm Type
Active Comparator
Arm Description
Patients with with Ultimaster® Drug-eluting stent in first lesion
Arm Title
Ultimaster® Drug-eluting stent in second lesion
Arm Type
Active Comparator
Arm Description
Patients with Coroflex® ISAR Drug-eluting stent in the first lesion
Intervention Type
Device
Intervention Name(s)
Coroflex® ISAR Drug-eluting stent
Intervention Description
Coroflex® ISAR Drug-eluting stent and an Ultimaster® Drug-eluting stent in the second lesion.
Intervention Type
Device
Intervention Name(s)
Ultimaster® Drug-eluting stent
Intervention Description
Ultimaster® Drug-eluting stent and a Coroflex® ISAR Drug-eluting stent in the second lesion.
Primary Outcome Measure Information:
Title
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
Title
Percentage of covered struts at 3 months OCT after stent implantation.
Time Frame
3 months
Title
Percentage of stents with ≥3% of uncovered struts at 3 months OCT after stent implantation.
Time Frame
3 months
Title
Percentage of uncovered struts ≥3% at 3 months OCT after stent implantation.
Time Frame
3 months
Title
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
Secondary Outcome Measure Information:
Title
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
Title
Total Tissue coverage at 1month, 2 months and 3 months OCT after stent implantation.
Time Frame
1 month and 2 months and 3 months
Title
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
Title
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
Title
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
Title
Percentage of stent malapposition at 1 month and 3 months OCT after stent implantation.
Time Frame
1 month and 2 months and 3 months
Title
Percentage of struts malapposition at 1 month and 3 months OCT after stent implantation.
Time Frame
1 month and 2 months and 3 months
Title
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
Title
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
Title
Healing Score at 1 month and 3 months OCT after stent implantation .
Time Frame
1 month and 2 months and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno García del Blanco, MD, PhD
Organizational Affiliation
Hospital Universitari Vall d'Hebron (Barcelona)
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de León
City
León
ZIP/Postal Code
24008
Country
Spain

12. IPD Sharing Statement

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

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