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Completed

NCT Number: NCT03049657

Efficacy of Angiolite Stent vs a Second-generation Drug-eluting Stent Xience for 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)

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Drug-Eluting Stent Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario de Santiago de Compostela, Santiago de Compostela, A Coruña, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Angiolite

Device

Percutaneous coronary intervention

Xience

Device

Percutaneous coronary intervention

Primary outcomes

  1. 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

    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)

  2. 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

    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

Secondary outcomes

  1. Follow up

    Time frame: 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

  2. Thrombosis rate

    Time frame: 1 year

    Discard differences in definite and probable thrombosis rate (according to Academic Research Consortium criteria) between both stents Angiolite and Xience

  3. MACE (Major Adverse Cardiac Events)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cardiva2 S.L.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
Feb 10, 2017
Registry last updated
Apr 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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