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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03049657
• Date of registration: 06/02/2017
• Prospective Registration: No
• Primary sponsor: Cardiva2 S.L.
• Public title: Efficacy of Angiolite Stent vs a Second-generation Drug-eluting Stent Xience for Percutaneous Coronary Intervention
• Scientific 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
• Date of first enrolment: February 2, 2016
• Target sample size: 220
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03049657
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Spain

Contacts

• Name: Carlos Ibares
• Affiliation: Cardiva2 S.L.

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Coronary Artery Disease

Drug-eluting Stent

Intervention(s)

Device: Xience

Device: Angiolite

Primary Outcome(s)

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) [Time Frame: 6 months]

Safety:Compare TLF rate (cardiovascular death, target vessel-related myocardial infarction (MI) with definite thrombosis or ischemia-driven Target Lesion Revascularization (TLR)) [Time Frame: 1 year]

Secondary Outcome(s)

MACE (Major Adverse Cardiac Events) [Time Frame: 1 year]

Follow up [Time Frame: 1 year]

Thrombosis rate [Time Frame: 1 year]

Secondary ID(s)

ANGIOLITE

Source(s) of Monetary Support

Please refer to primary and secondary sponsors