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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03049657
• Other study ID #: ANGIOLITE
• Status: Completed
• Phase: N/A
• Start date: February 2, 2016
• Est. completion date: January 28, 2019

Study information

• Verified date: April 2019
• Source: Cardiva2 S.L.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: January 28, 2019
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Drug-eluting Stent
• Myocardial Ischemia

Intervention

Device:
• Angiolite
Percutaneous coronary intervention
• Xience
Percutaneous coronary intervention

Locations

Country	Name	City	State
Spain	Hospital Infanta Cristina	Badajoz
Spain	Hospital Valle de Hebrón	Barcelona
Spain	Hospital Virgen de la Arrixaca	El Palmar	Murcia
Spain	Hospital Virgen de las Nieves	Granada
Spain	Hospital Juan Ramón Jiménez	Huelva
Spain	Hospital de León	Leon	León
Spain	Hospital La Paz	Madrid
Spain	Hospital Marqués de Valdecilla	Santander
Spain	Hospital Universitario de Santiago de Compostela	Santiago de Compostela	A Coruña
Spain	Hospital Virgen de la Salud	Toledo
Spain	Hospital Clinico Universitario de Valladolid	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
Cardiva2 S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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
Primary	Safety:Compare TLF rate (cardiovascular death, target vessel-related myocardial infarction (MI) with definite thrombosis or ischemia-driven Target Lesion Revascularization (TLR))	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	1 year
Secondary	Follow up	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	1 year
Secondary	Thrombosis rate	Discard differences in definite and probable thrombosis rate (according to Academic Research Consortium criteria) between both stents Angiolite and Xience	1 year
Secondary	MACE (Major Adverse Cardiac Events)	- Compare the differences between the rate of MACE (all-cause death, any myocardial infarction and any revascularization) of Angiolite and Xience during follow-up	1 year