Clinical trial NCT03049657: Efficacy of Angiolite Stent vs a Second-generation Drug-eluting Stent Xience for Percutaneous Coronary Intervention
Official title: Randomized Clinical Trial to Compare the Efficacy of Angiolite Stent Versus a Second-generation Drug-eluting Stent Such as Xience in Patients With Indication of Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Drug-eluting Stent
Lead sponsor: Cardiva2 S.L.
Sponsor class: INDUSTRY
First posted: 2017-02-10
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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)


Eligibility criteria: 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

Primary outcomes:
measure: Efficacy:Measure the late loss (LL) in the follow-up of the Angiolite stent is not different from the late loss of the xience stent (non-inferiority)
timeFrame: 6 months
measure: Safety:Compare TLF rate (cardiovascular death, target vessel-related myocardial infarction (MI) with definite thrombosis or ischemia-driven Target Lesion Revascularization (TLR))
timeFrame: 1 year
Secondary outcomes:
measure: Follow up
timeFrame: 1 year
measure: Thrombosis rate
timeFrame: 1 year
measure: MACE (Major Adverse Cardiac Events)
timeFrame: 1 year
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: Hospital Universitario de Santiago de Compostela
state: A Coruña
city: Leon
country: Spain
facility: Hospital de León
state: León
city: El Palmar
country: Spain
facility: Hospital Virgen de la Arrixaca
state: Murcia
city: Badajoz
country: Spain
facility: Hospital Infanta Cristina
city: Barcelona
country: Spain
facility: Hospital Valle de Hebrón
city: Granada
country: Spain
facility: Hospital Virgen de las Nieves
city: Huelva
country: Spain
facility: Hospital Juan Ramón Jiménez
city: Madrid
country: Spain
facility: Hospital La Paz
city: Santander
country: Spain
facility: Hospital Marqués de Valdecilla
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid
Study officials:
affiliation: Cardiva2 S.L.
name: Carlos Ibares
role: STUDY_DIRECTOR
References: