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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-02

Study Completion Date

2019-01-28

Brief Summary

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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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Detailed Description

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Conditions

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Coronary Artery Disease Drug-eluting Stent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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ANGIOLITE

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

Group Type ACTIVE_COMPARATOR

Angiolite

Intervention Type DEVICE

Percutaneous coronary intervention

Xience

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

Group Type ACTIVE_COMPARATOR

Xience

Intervention Type DEVICE

Percutaneous coronary intervention

Interventions

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Angiolite

Percutaneous coronary intervention

Intervention Type DEVICE

Xience

Percutaneous coronary intervention

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No