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

Not Applicable

Completed

• Conditions: Drug-eluting Stent; Coronary Artery Disease
• Interventions: Device: Xience; Device: Angiolite

• Registration Number: NCT03049657
• Lead Sponsor: Cardiva2 S.L.

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-02
• Study First Submitted: 2017-02-06
• Study First Submitted QC: 2017-02-09
• Study First Posted: 2017-02-10
• Primary Completion: 2017-03-31
• Study Completion: 2019-01-28
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-11
• Last Update Posted: 2019-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xience	Xience	Compare the efficacy of Angiolite Stent versus a second-generation drug-eluting stent such as Xience stent.
ANGIOLITE	Angiolite	Compare the efficacy of Angiolite Stent versus a second-generation drug-eluting stent such as Xience stent.

Primary Outcome Measures

Name	Time	Method
Safety:Compare TLF rate (cardiovascular death, target vessel-related myocardial infarction (MI) with definite thrombosis or ischemia-driven Target Lesion Revascularization (TLR))	1 year	Compare TLF rate (cardiovascular death, target vessel-related myocardial infarction (MI) with definite thrombosis or ischemia-driven Target Lesion Revascularization (TLR)) during follow-up for no differences between Angiolite and Xience stents
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)	6 months	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)

Secondary Outcome Measures

Name	Time	Method
Thrombosis rate	1 year	Discard differences in definite and probable thrombosis rate (according to Academic Research Consortium criteria) between both stents Angiolite and Xience
Follow up	1 year	Compare differences between Angiolite and Xience stent during the follow-up in independent components of the major adverse cardiac events rate: All cause death, any myocardial infarction and any revascularization
MACE (Major Adverse Cardiac Events)	1 year	- Compare the differences between the rate of MACE (all-cause death, any myocardial infarction and any revascularization) of Angiolite and Xience during follow-up

Trial Locations

Locations (11)

Hospital Infanta Cristina; 🇪🇸 Badajoz, Spain

Hospital Universitario de Santiago de Compostela; 🇪🇸 Santiago de Compostela, A Coruña, Spain

Hospital de León; 🇪🇸 Leon, León, Spain

Hospital Virgen de la Arrixaca; 🇪🇸 El Palmar, Murcia, Spain

Hospital Valle de Hebrón; 🇪🇸 Barcelona, Spain

Hospital Virgen de la Salud; 🇪🇸 Toledo, Spain

Hospital Virgen de las Nieves; 🇪🇸 Granada, Spain

Hospital Juan Ramón Jiménez; 🇪🇸 Huelva, Spain

Hospital La Paz; 🇪🇸 Madrid, Spain

Hospital Clinico Universitario de Valladolid; 🇪🇸 Valladolid, Spain

Hospital Marqués de Valdecilla; 🇪🇸 Santander, Spain