NCT02785237CompletedNot Applicable
Intra-patient Randomized Study With Polymer Free Drug Eluting Stent Versus Abluminal Biodegradable Polymer Drug Eluting Stent With Early OCT Follow up
Hospital Universitari Vall d'Hebron Research Institute6 sites in 1 country70 target enrollmentStarted: June 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 70
- Locations
- 6
- Primary Endpoint
- Percentage of covered struts at 3 months OCT after stent implantation.
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Percentage of covered struts at 3 months OCT after stent implantation.
Time Frame: 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
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
Percentage of uncovered struts ≥3% at 3 months OCT after stent implantation.
Time Frame: 3 months
Percentage of stents with ≥3% of uncovered struts at 3 months OCT after stent implantation.
Time Frame: 3 months
Secondary Outcomes
- Percentage of covered struts, 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)
- Percentage of stent malapposition at 1 month and 3 months OCT after stent implantation.(1 month and 2 months and 3 months)
- Percentage of struts malapposition at 1 month and 3 months OCT after stent implantation.(1 month and 2 months and 3 months)
- Percentage of struts malapposition> 260 µm at 1 month and 3 months OCT after stent implantation.(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.(1 month and 2 months and 3 months)
- Healing Score at 1 month 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)
- 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)
Investigators
Study Sites (6)
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