Coronary Artery DiseaseNCT03049657
Efficacy of Angiolite Stent vs a Second-generation Drug-eluting Stent Xience for Percutaneous Coronary Intervention
A study testing Angiolite and Xience in people with Coronary Artery Disease and Drug-eluting Stent, run by Cardiva2 S.L. at 11 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Drug-eluting Stent
- What is being tested?
- Angiolite and Xience
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 11 sitesSpain
- Study dates
- 2 Feb 2016to 28 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 11Show fewer
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Spain11 sites
Hospital Infanta Cristina
Badajoz, 06006
Hospital Valle de Hebrón
Barcelona, 08035
Hospital Virgen de la Arrixaca
El Palmar, Murcia, 30120
Hospital Virgen de las Nieves
Granada, 18014
Hospital Juan Ramón Jiménez
Huelva, 21005
Hospital de León
León, León, 24001
Hospital La Paz
Madrid, 28046
Hospital Marqués de Valdecilla
Santander, 39008
Hospital Universitario de Santiago de Compostela
Santiago de Compostela, A Coruña, 15706
Hospital Virgen de la Salud
Toledo, 45005
Hospital Clinico Universitario de Valladolid
Valladolid, 47003
About this study
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
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)
- Conditions
- Coronary Artery Disease, Drug-eluting Stent
- Being tested
- Angiolite, Xience
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AngioliteDevice
Percutaneous coronary intervention
XienceDevice
Percutaneous coronary intervention
| Study group | Role | What they receive |
|---|---|---|
| ANGIOLITE | Active comparator | Compare the efficacy of Angiolite Stent versus a second-generation drug-eluting stent such as Xience stent. Receives: Device: Angiolite |
| Xience | Active comparator | Compare the efficacy of Angiolite Stent versus a second-generation drug-eluting stent such as Xience stent. Receives: Device: Xience |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 1 year
Secondary outcomes (3)
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
Measured: 1 year
Thrombosis rate
Discard differences in definite and probable thrombosis rate (according to Academic Research Consortium criteria) between both stents Angiolite and Xience
Measured: 1 year
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2017
- Study start2 Feb 2016
- Primary completion31 Mar 2017
- Study completion28 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiva2 S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlos Ibares, Study director, Cardiva2 S.L.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03049657
- Sponsor's protocol ID
- ANGIOLITE
- Status last verified
- Apr 2019
- First submitted
- 6 Feb 2017
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03049657
- Acronym / sponsor ID
- ANGIOLITE
- Conditions
- Coronary Artery Disease, Drug-eluting Stent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Cardiva2 S.L.Industry (pharma, biotech, devices)
- Study start
- 2 Feb 2016 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 28 Jan 2019 (actual)
- First posted
- 10 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ANGIOLITE | Active comparator | Device: AngioliteCompare the efficacy of Angiolite Stent versus a second-generation drug-eluting stent such as Xience stent. |
| Xience | Active comparator | Device: XienceCompare the efficacy of Angiolite Stent versus a second-generation drug-eluting stent such as Xience stent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AngiolitePercutaneous coronary intervention | Device | ANGIOLITE |
| XiencePercutaneous coronary intervention | Device | Xience |
Primary outcome
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)
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
3 secondary outcomes
Follow up
Time frame: 1 year
Thrombosis rate
Time frame: 1 year
MACE (Major Adverse Cardiac Events)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Ibares study director
Cardiva2 S.L.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Angiolite and Xience in people with Coronary Artery Disease and Drug-eluting Stent, run by Cardiva2 S.L. at 11 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2019.