Efficacy of Angiolite Stent vs a Second-generation Drug-eluting Stent Xience for Percutaneous Coronary Intervention

Cardiva2

Status

Completed

Conditions

Drug-eluting Stent

Coronary Artery Disease

Treatments

Device: Xience

Device: Angiolite

Study type

Interventional

Funder types

Industry

Identifiers

NCT03049657

ANGIOLITE

Details and patient eligibility

About

Clinical trial with an "European Community marked" medical device in patients with ischemic heart disease and clinical indication of coronary revascularization with drug-eluting stent.

Clinical follow-up will be done according to this way: first month telephone or face-to-face interview and at 6 ± 1 month an Angiography follow up + OCT (optical coherence tomography)

A randomized clinical trial to compare the efficacy of Angiolite Stent versus a second-generation drug-eluting stent such as Xience stent.(non-inferiority design)

Enrollment

220 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with clinical or subclinical ischemic heart disease with indication of percutaneous revascularization.
"De Novo" lesions ≥ 70%
Reference diameters ≥ 2 mm and ≤ 4 mm Accepted participation in the registration with the signing of informed consent

Exclusion criteria

Cardiogenic shock
Pregnancy
Intolerance or allergy to anti platelet or anticoagulant therapy
Elective surgical procedure scheduled within 6 months after inclusion in the study
Expectancy of life of less than 1 year.
Impossibility of doing 1 year clinical follow-up.
Primary angioplasty in patients with killip class III-IV or mechanical complications.
Patient with pre-procedure restenosis.
Patients who will not be treated all lesions with the Angiolite stent.
Total occlusions
Truncus disease