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

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Coroflex® ISAR Drug-eluting stent; Device: Ultimaster® Drug-eluting stent

• Registration Number: NCT02785237
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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 Timeline

• Study First Submitted: 2016-05-20
• Study First Submitted QC: 2016-05-26
• Study First Posted: 2016-05-27
• Study Start: 2016-06
• Status Verified: 2019-01
• Primary Completion: 2019-01-01
• Study Completion: 2019-01-01
• Last Update Submitted: 2019-01-02
• Last Update Posted: 2019-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coroflex® ISAR Drug-eluting stent in first lesion	Coroflex® ISAR Drug-eluting stent	Patients with Coroflex® ISAR Drug-eluting stent in the first lesion
Ultimaster® Drug-eluting stent in first lesion	Ultimaster® Drug-eluting stent	Patients with Ultimaster® Drug-eluting stent in first lesion
Coroflex® ISAR Drug-eluting stent in second lesion	Coroflex® ISAR Drug-eluting stent	Patients with with Ultimaster® Drug-eluting stent in first lesion
Ultimaster® Drug-eluting stent in second lesion	Ultimaster® Drug-eluting stent	Patients with Coroflex® ISAR Drug-eluting stent in the first lesion

Primary Outcome Measures

Name	Time	Method
Percentage of covered struts 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
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 uncovered struts ≥3% 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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Spain

Hospital de León; 🇪🇸 León, Spain