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

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 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)

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Drug-eluting Stent
• Intervention / Treatment: Device: Angiolite; Device: Xience

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Badajoz, Spain, 06006
    • Hospital Infanta Cristina
  • Barcelona, Spain, 08035
    • Hospital Valle de Hebron
  • Granada, Spain, 18014
    • Hospital Virgen de las Nieves
  • Huelva, Spain, 21005
    • Hospital Juan Ramón Jimenez
  • Madrid, Spain, 28046
    • Hospital La Paz
  • Santander, Spain, 39008
    • Hospital Marques de Valdecilla
  • Toledo, Spain, 45005
    • Hospital Virgen de la Salud
  • Valladolid, Spain, 47003
    • Hospital Clínico Universitario de Valladolid
  • A Coruña
    • Santiago de Compostela, A Coruña, Spain, 15706
      • Hospital Universitario de Santiago de Compostela
  • León
    • Leon, León, Spain, 24001
      • Hospital de León
  • Murcia
    • El Palmar, Murcia, Spain, 30120
      • Hospital Virgen de la Arrixaca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ANGIOLITE; Compare the efficacy of Angiolite Stent versus a second-generation drug-eluting stent such as Xience stent.	Device: Angiolite; Percutaneous coronary intervention
Active Comparator: Xience; Compare the efficacy of Angiolite Stent versus a second-generation drug-eluting stent such as Xience stent.	Device: Xience; Percutaneous coronary intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Thrombosis rate	Discard differences in definite and probable thrombosis rate (according to Academic Research Consortium criteria) between both stents Angiolite and Xience	1 year
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

Collaborators and Investigators

• Sponsor: Cardiva2 S.L.
• Investigators: Study Director: Carlos Ibares, Cardiva2 S.L.

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2016
• Primary Completion (Actual): March 31, 2017
• Study Completion (Actual): January 28, 2019

Study Registration Dates

• First Submitted: February 6, 2017
• First Submitted That Met QC Criteria: February 9, 2017
• First Posted (Actual): February 10, 2017

Study Record Updates

• Last Update Posted (Actual): April 12, 2019
• Last Update Submitted That Met QC Criteria: April 11, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: ANGIOLITE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No