NCT03049657

Brief 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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 6, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 10, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2019

Completed
Last Updated

April 12, 2019

Status Verified

April 1, 2019

Enrollment Period

1.2 years

First QC Date

February 6, 2017

Last Update Submit

April 11, 2019

Conditions

Coronary Artery DiseaseDrug-eluting Stent

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Follow up

    1 year

  • Thrombosis rate

    1 year

  • MACE (Major Adverse Cardiac Events)

    1 year

Study Arms (2)

ANGIOLITE

ACTIVE COMPARATOR

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

Device: Angiolite

Xience

ACTIVE COMPARATOR

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

Device: Xience

Interventions

AngioliteDEVICE

Percutaneous coronary intervention

ANGIOLITE
XienceDEVICE

Percutaneous coronary intervention

Xience

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Cardiogenic shock
  • Pregnancy
  • Intolerance or allergy to anti platelet or anticoagulant therapy
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Hospital Universitario de Santiago de Compostela

Santiago de Compostela, A Coruña, 15706, Spain

Location

Hospital de León

León, León, 24001, Spain

Location

Hospital Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

Location

Hospital Infanta Cristina

Badajoz, 06006, Spain

Location

Hospital Valle de Hebrón

Barcelona, 08035, Spain

Location

Hospital Virgen de las Nieves

Granada, 18014, Spain

Location

Hospital Juan Ramón Jiménez

Huelva, 21005, Spain

Location

Hospital La Paz

Madrid, 28046, Spain

Location

Hospital Marqués de Valdecilla

Santander, 39008, Spain

Location

Hospital Virgen de la Salud

Toledo, 45005, Spain

Location

Hospital Clinico Universitario de Valladolid

Valladolid, 47003, Spain

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Carlos Ibares

    Cardiva2 S.L.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2017

First Posted

February 10, 2017

Study Start

February 2, 2016

Primary Completion

March 31, 2017

Study Completion

January 28, 2019

Last Updated

April 12, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(11)