Clinical trial NCT02785237: 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
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Drug-eluting stent
OCT
Re-endothelialization
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: B.Braun Surgical SA
First posted: 2016-05-27
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: 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.
timeFrame: 3 months
measure: Percentage of covered struts at 3 months OCT after stent implantation.
timeFrame: 3 months
measure: Percentage of stents with ≥3% of uncovered struts at 3 months OCT after stent implantation.
timeFrame: 3 months
measure: Percentage of uncovered struts ≥3% at 3 months OCT after stent implantation.
timeFrame: 3 months
measure: Number of transversal sections with a percentage (rate of uncovered struts/ total number of struts) > 30 % at 3 months OCT after stent implantation.
timeFrame: 3 months
Secondary outcomes:
measure: Percentage of covered struts, at 1 month, 2 months and 3 months OCT after stent implantation.
timeFrame: 1 month and 2 months and 3 months
measure: Total Tissue coverage at 1month, 2 months and 3 months OCT after stent implantation.
timeFrame: 1 month and 2 months and 3 months
measure: Mean thickness of struts tissue coverage at 1 month, 2 months and 3 months OCT after stent implantation.
timeFrame: 1 month and 2 months and 3 months
measure: MACE (Major Adverse Cardiac Events) at 30 days, 3 months, 6 months and 12 months.
timeFrame: 30 days and 3 months and 6 months and 12 months
measure: Target lesion revascularization and target vessel revascularization at 30 days, 3 months, 6 months and 12 months OCT after stent implantation .
timeFrame: 30 days and 3 months and 6 months and 12 months
measure: Percentage of stent malapposition at 1 month and 3 months OCT after stent implantation.
timeFrame: 1 month and 2 months and 3 months
measure: Percentage of struts malapposition at 1 month and 3 months OCT after stent implantation.
timeFrame: 1 month and 2 months and 3 months
measure: Percentage of struts malapposition> 260 µm at 1 month and 3 months OCT after stent implantation.
timeFrame: 1 month and 2 months and 3 months
measure: Percentage of stents with any malapposition strut > 260 µm at 1 month and 3 months OCT after stent implantation.
timeFrame: 1 month and 2 months and 3 months
measure: Healing Score at 1 month and 3 months OCT after stent implantation .
timeFrame: 1 month and 2 months and 3 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: León
country: Spain
facility: Hospital de León
Study officials:
affiliation: Hospital Universitari Vall d'Hebron (Barcelona)
name: Bruno García del Blanco, MD, PhD
role: STUDY_DIRECTOR
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