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

Primary Purpose

Coronary Artery Disease, Drug-eluting Stent

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Angiolite
Xience
Sponsored by
Cardiva2 S.L.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitario de Santiago de Compostela
  • Hospital de León
  • Hospital Virgen de la Arrixaca
  • Hospital Infanta Cristina
  • Hospital Valle de Hebrón
  • Hospital Virgen de las Nieves
  • Hospital Juan Ramón Jiménez
  • Hospital La Paz
  • Hospital Marqués de Valdecilla
  • Hospital Virgen de la Salud
  • Hospital Clinico Universitario de Valladolid

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ANGIOLITE

Xience

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)
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

Secondary Outcome Measures

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

Full Information

First Posted
February 6, 2017
Last Updated
April 11, 2019
Sponsor
Cardiva2 S.L.
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1. Study Identification

Unique Protocol Identification Number
NCT03049657
Brief Title
Efficacy of Angiolite Stent vs a Second-generation Drug-eluting Stent Xience for Percutaneous Coronary Intervention
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
February 2, 2016 (Actual)
Primary Completion Date
March 31, 2017 (Actual)
Study Completion Date
January 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cardiva2 S.L.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Drug-eluting Stent

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ANGIOLITE
Arm Type
Active Comparator
Arm Description
Compare the efficacy of Angiolite Stent versus a second-generation drug-eluting stent such as Xience stent.
Arm Title
Xience
Arm Type
Active Comparator
Arm Description
Compare the efficacy of Angiolite Stent versus a second-generation drug-eluting stent such as Xience stent.
Intervention Type
Device
Intervention Name(s)
Angiolite
Intervention Description
Percutaneous coronary intervention
Intervention Type
Device
Intervention Name(s)
Xience
Intervention Description
Percutaneous coronary intervention
Primary Outcome Measure Information:
Title
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)
Description
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
Title
Safety:Compare TLF rate (cardiovascular death, target vessel-related myocardial infarction (MI) with definite thrombosis or ischemia-driven Target Lesion Revascularization (TLR))
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Follow up
Description
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
Time Frame
1 year
Title
Thrombosis rate
Description
Discard differences in definite and probable thrombosis rate (according to Academic Research Consortium criteria) between both stents Angiolite and Xience
Time Frame
1 year
Title
MACE (Major Adverse Cardiac Events)
Description
- Compare the differences between the rate of MACE (all-cause death, any myocardial infarction and any revascularization) of Angiolite and Xience during follow-up
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Ibares
Organizational Affiliation
Cardiva2 S.L.
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Universitario de Santiago de Compostela
City
Santiago de Compostela
State/Province
A Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital de León
City
Leon
State/Province
León
ZIP/Postal Code
24001
Country
Spain
Facility Name
Hospital Virgen de la Arrixaca
City
El Palmar
State/Province
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Hospital Infanta Cristina
City
Badajoz
ZIP/Postal Code
06006
Country
Spain
Facility Name
Hospital Valle de Hebrón
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Virgen de las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Hospital Juan Ramón Jiménez
City
Huelva
ZIP/Postal Code
21005
Country
Spain
Facility Name
Hospital La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Marqués de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Virgen de la Salud
City
Toledo
ZIP/Postal Code
45005
Country
Spain
Facility Name
Hospital Clinico Universitario de Valladolid
City
Valladolid
ZIP/Postal Code
47003
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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