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

Launched by HOSPITAL UNIVERSITARI VALL D'HEBRON RESEARCH INSTITUTE · May 26, 2016

Keywords

ClinConnect 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

Gender

ALL

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