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

Vall d'Hebron University Hospital (HUVH)

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: Coroflex® ISAR Drug-eluting stent; Device: Ultimaster® Drug-eluting stent

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02785237

FRIENDLY OCT

Details and patient eligibility

About

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

Full 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

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 4 patient groups

Coroflex® ISAR Drug-eluting stent in first lesion

Active Comparator group

Description:

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

Treatment:

Device: Coroflex® ISAR Drug-eluting stent

Ultimaster® Drug-eluting stent in first lesion

Active Comparator group

Description:

Patients with Ultimaster® Drug-eluting stent in first lesion

Treatment:

Device: Ultimaster® Drug-eluting stent

Coroflex® ISAR Drug-eluting stent in second lesion

Active Comparator group

Description:

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

Treatment:

Device: Coroflex® ISAR Drug-eluting stent

Ultimaster® Drug-eluting stent in second lesion

Active Comparator group

Description:

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

Treatment:

Device: Ultimaster® Drug-eluting stent