Coronary Artery DiseasePhase 3ANGIODAPTNCT05952206
Ischemic and Bleeding Outcomes After Angiolite Stent Implantation and an Abbreviated Dual Antiplatelet Therapy
A Phase 3 study testing Angiolite: Sirolimus-eluting stent, Xience: Everolimus-eluting stent and 1-month DAPT in people with Coronary Artery Disease, run by iVascular S.L.U. at 38 sites in 3 countries.
Trial summary
Factorial 2x2, all-comer, multicentre, randomized controlled trial (ratio 1:1:1:1). First, the study will compare (first randomization) the non-inferiority in target lesion failure of angiolite stent versus Xience stent family. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Angiolite: Sirolimus-eluting stent, Xience: Everolimus-eluting stent and 1-month DAPT
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,312 participants
- Where
- 38 sitesin 3 countries
- Study dates
- 13 Oct 2023to 13 Jan 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 - < 95 years;
- Presence of one or more coronary artery stenosis of 50% or more in a native coronary artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation. The vessel should have a reference vessel diameter of at least 2.00 mm (no limitation on the number of treated lesions, vessels, or lesion length);
- Able to provide informed consent and willing to participate in the trial.
Who cannot join
- Known intolerance to acetylsalicylic acid, P2Y12 inhibitors (clopidogrel, prasugrel, or ticagrelor), sirolimus, everolimus, or chromium-cobalt.;
- Known severe hepatic impairment Child-Pug stage C;
- Prior PCI (not related to the study) performed in the last 45 days;
- Planned non-cardiac surgery during the first month after PCI, unless dual antiplatelet therapy is maintained throughout the peri-surgical period;
- Planned coronary artery bypass graft (CABG) or any other cardiac surgery (valvular for instance) following index PCI;
- Active major bleeding or major surgery within the last 30 days;
Show all 10Show fewer
- Known stroke (any type) within the 30 days prior to the randomization;
- Women of childbearing potential being defined as woman from the onset of menstruation (menarche) until they become postmenopausal, unless they are permanently sterile. A postmenopausal state is clarified as having no menstrual periods for 12 consecutive months without any other medical cause. Women who have undergone permanent sterilization methods, including hysterectomy, bilateral salpingectomy, and bilateral oophorectomy, can be enrolled in the study
- Currently participating in another randomized controlled trial and not yet at its primary endpoint;
- Life expectancy less than one year due to non-cardiovascular comorbidity.
Trial locations and contacts
38 sites in 3 countries.
38 sites in 3 countries
Spain26 sites
Complejo Hospitalario Universitario A Coruña
A Coruña
Complejo Hospitalario Torrecárdenas
Almería
Hospital Clínic de Barcelona
Barcelona
Hospital de La Santa Creu I Sant Pau
Barcelona
Hospital Germans Trias I Pujol
Barcelona
Hospital Universitario de Bellvitge
Barcelona
Hospital Universitario Vall D'Hebrón
Barcelona
Hospital San Pedro de Alcantara
Cáceres
Hospital Universitario Juan Ramón Jiménez
Huelva
Hospital Universitario Jerez de La Frontera
Jerez de la Frontera
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria
Hospital Universitario de León
León
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario Puerta de Hierro
Madrid
Hospital Universitario Regional de Málaga
Málaga
Hospital Universitario Virgen de La Victoria
Málaga
Hospital Clínico Universitario Virgen de La Arrixaca
Murcia
Hospital Universitari Son Espases
Palma de Mallorca
Hospital de Navarra
Pamplona
Hospital Universitario Marqués de Valdecilla
Santander
Hospital Clínico Universitario de Santiago
Santiago de Compostela
Hospital Clínico Universitario de Valencia
Valencia
Hospital Universitario Y Politécnico La Fe
Valencia
Hospital Clínico Universitario de Valladolid
Valladolid
Hospital Álvaro Cunqueiro
Vigo
Hospital Universitario Miguel Servet
Zaragoza
Belgium8 sites
IMELDA
Bonheiden
CHU Marie Curie
Charleroi
ZOL GENK
Genk
CHC Montlégia
Liège
Hospital de La Citadelle
Liège
Chu Ambroise Pare
Mons
Az Delta
Roeselare
Az Turnhout
Turnhout
France4 sites
Chu Lille
Lille
Icps Massy
Massy
Ipcs Quincy
Quincy-sous-Sénart
Chu Toulouse
Toulouse
About this study
Official title: Ischemic and Bleeding Outcomes After Angiolite Stent Implantation and an Abbreviated Dual Antiplatelet Therapy. A 2x2 Factorial, All-comer, Multicenter, Randomized Controlled Trial: ANGIODAPT
Factorial 2x2, all-comer, multicentre, randomized controlled trial (ratio 1:1:1:1). First, the study will compare (first randomization) the non-inferiority in target lesion failure of angiolite stent versus Xience stent family. Immediately after the first randomization, the study compares (second randomization) the superiority in bleeding Bleeding Academic Research Consortium (BARC) 2, 3, or 5 of abbreviated DAPT versus standard of care. Both primary endpoints will be evaluated at 12 months of follow-up. The study will be open-label for the stent type and the antiplatelet regimen.
- Conditions
- Coronary Artery Disease
- Being tested
- Angiolite: Sirolimus-eluting stent, Xience: Everolimus-eluting stent, 1-month DAPT, 12-month DAPT (Standard of care)
- Keywords
- angiolite, dual antiplatelet therapy, percutaneous coronary intervention
- 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.
Angiolite: Sirolimus-eluting stentDevice
Also called iVascular angiolite
The angiolite stent (iVascular, Barcelona, Spain) is a thin-strut cobalt-chromium sirolimus-eluting stent with an open-cell design containing a durable biostable coating composed of three layers - acrylate to ensure adhesion to the metal surface, fluoroacrylate that carries the sirolimus, and a top layer of fluoroacrylate to control drug release.
Xience: Everolimus-eluting stentDevice
Also called Xience stent family
The Xience stent family (Abbott vascular, California, United States of America), characterized by an L-605 cobalt-chromium (CoCr) is a thin-strut cobalt-chromium everolimus-eluting stent with an open-cell design containing a nonerodable polymer made of PBMA, a reservoir made of a fluorinated copolymer of vinylidene fluoride and hexafluoropropylene monomers. Xience™ stent family includes XIENCE Skypoint™ and XIENCE Sierra™
1-month DAPTDrug
DAPT with acetylsalicylic acid + prasugrel or ticagrelor for 1 month. Then, only the same oral P2Y12 inhibitor (clopidogrel, prasugrel, and ticagrelor) up to 12 months.
The type of agent and treatment duration will be selected according to the clinical characteristic of the patient: Acute coronary syndrome or Chronic coronary syndrome and Need for OAC or No need for OAC
12-month DAPT (Standard of care)Drug
DAPT with acetylsalicylic acid and prasugrel or ticagrelor up to 12 months. The type of agent and treatment duration will be selected according to the clinical characteristic of the patient: Acute coronary syndrome or Chronic coronary syndrome and Need for OAC or No need for OAC
| Study group | Role | What they receive |
|---|---|---|
| Angiolite and abbreviated DAPT | Experimental | Acute coronary syndrome patients:
* Need for OAC: TAT + OAC for one week. Double therapy composed of clopidogrel + OAC up to 6 months.
* No need for OAC: DAPT with acetylsalicylic acid + prasugrel or ticagrelor for 1M. Only the same P2Y12 inhibitor up to 12M.
Chronic coronary syndrome patients:
* Need for OAC: TAT + clopidogrel + OAC for one week. Double therapy composed of clopidogrel + OAC up to 6M.
* No need for OAC: DAPT with acetylsalicylic acid + clopidogrel for one month. Only clopidogrel up to 12M. Receives: Device: Angiolite: Sirolimus-eluting stent; Drug: 1-month DAPT |
| Xience stent family and abbreviated DAPT | Experimental | Acute coronary syndrome patients:
* Need for OAC: TAT + OAC for one week. Double therapy composed of clopidogrel + OAC up to 6M.
* No need for OAC: DAPT with acetylsalicylic acid + prasugrel or ticagrelor for 1 month. Only the same P2Y12 inhibitor up to 12M.
Chronic coronary syndrome patients:
* Need for OAC: TAT + clopidogrel + OAC for one week. Double therapy composed of clopidogrel + OAC up to 6M.
* No need for OAC: DAPT with acetylsalicylic acid + clopidogrel for one month. Only clopidogrel up to 12M. Receives: Device: Xience: Everolimus-eluting stent; Drug: 1-month DAPT |
| Angiolite and standard of care DAPT | Active comparator | Acute coronary syndrome patients:
* Need for OAC: Recommendations of the current ESC guideline: 1M of TAT (acetylsalicylic acid + clopidogrel + OAC). Dual therapy (acetylsalicylic acid or clopidogrel + OAC) up to 12M. If ischemic concerns prevail, TAT can be extended up to 6M and dual therapy up to 12M.
* No need for OAC: Recommendations of the current ESC guideline: DAPT with acetylsalicylic acid and prasugrel or ticagrelor is recommended up to 12M.
Chronic coronary syndrome:
* Need for OAC: Recommendations of the current ESC guidelines: 1M of TAT (acetylsalicylic acid + clopidogrel + OAC). Dual therapy (acetylsalicylic acid or clopidogrel + OAC) up to 12M. If ischemic concerns prevail, TAT can be extended up to 6M and dual therapy up to 12M.
* No need for OAC: Recommendations of the current ESC guidelines: DAPT composed of acetylsalicylic acid + clopidogrel up to 6M. Then, continue with acetylsalicylic acid. Receives: Device: Angiolite: Sirolimus-eluting stent; Drug: 12-month DAPT (Standard of care) |
| Xience stent family and standard of care DAPT | Active comparator | Acute coronary syndrome patients:
* Need for OAC: Recommendations of the current ESC guideline: 1M of TAT (acetylsalicylic acid + clopidogrel + OAC). Dual therapy (acetylsalicylic acid or clopidogrel + OAC) up to 12M. If ischemic concerns prevail, TAT can be extended up to 6M and dual therapy up to 12M.
* No need for OAC: Recommendations of the current ESC guideline: DAPT with acetylsalicylic acid and prasugrel or ticagrelor is recommended up to 12M.
Chronic coronary syndrome:
* Need for OAC: Recommendations of the current ESC guidelines: 1M of TAT (acetylsalicylic acid + clopidogrel + OAC). Dual therapy (acetylsalicylic acid or clopidogrel + OAC) up to 12M. If ischemic concerns prevail, TAT can be extended up to 6M and dual therapy up to 12M.
* No need for OAC: Recommendations of the current ESC guidelines: DAPT composed of acetylsalicylic acid + clopidogrel up to 6M. Then, continue with acetylsalicylic acid. Receives: Device: Xience: Everolimus-eluting stent; Drug: 12-month DAPT (Standard of care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the rate of target lesion failure between angiolite stent and Xience stent family (tested for non-inferiority) in both the standard of care DAPT regimen and abbreviated antiplatelet therapy group.
Measured: 1 year
To determine the rate of clinically relevant bleeding events (BARC 2, 3, or 5) between an abbreviated DAPT regimen and the standard of care DAPT (tested for superiority of the experimental arm).
Measured: 1 year
Secondary outcomes (2)
To determine the rate of adverse ischemic events between an abbreviated dual antiplatelet therapy regimen and the standard of care dual antiplatelet therapy (tested for non-inferiority).
Measured: 1 year
Rate of target lesion failure between angiolite stent and Xience stent family (Skypoint or Sierra) (tested for non-inferiority) in the standard of care subgroup.
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 posted19 Jul 2023
- Study start13 Oct 2023
- Primary completion13 Jan 2027 (estimated)
- Study completion13 Jan 2030 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Phase III, prospective, randomized (1:1:1:1), factorial design 2x2, active control, and multicentre clinical trial.
- Masking
- None (open label)
- Enrolment
- 2,312 participants (actual)
Sponsor and investigators
- Lead sponsor
- iVascular S.L.U.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Manel Sabaté, Principal investigator, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05952206
- Sponsor's protocol ID
- ANGIODAPT-01
- Acronym
- ANGIODAPT
- Status last verified
- May 2026
- First submitted
- 24 May 2023
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ischemic and Bleeding Outcomes After Angiolite Stent Implantation and an Abbreviated Dual Antiplatelet Therapy. A 2x2 Factorial, All-comer, Multicenter, Randomized Controlled Trial: ANGIODAPT
- ClinicalTrials.gov ID
- NCT05952206
- Acronym / sponsor ID
- ANGIODAPT / ANGIODAPT-01
- Conditions
- Coronary Artery Disease
- Keywords
- angiolite, dual antiplatelet therapy, percutaneous coronary intervention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,312 participants (actual)
- Lead sponsor
- iVascular S.L.U.Industry (pharma, biotech, devices)
- Study start
- 13 Oct 2023 (actual)
- Primary completion
- 13 Jan 2027 (estimated)
- Study completion
- 13 Jan 2030 (estimated)
- First posted
- 19 Jul 2023 (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.
Factorial 2x2, all-comer, multicentre, randomized controlled trial (ratio 1:1:1:1). First, the study will compare (first randomization) the non-inferiority in target lesion failure of angiolite stent versus Xience stent family. Immediately after the first randomization, the study compares (second randomization) the superiority in bleeding Bleeding Academic Research Consortium (BARC) 2, 3, or 5 of abbreviated DAPT versus standard of care. Both primary endpoints will be evaluated at 12 months of follow-up. The study will be open-label for the stent type and the antiplatelet regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Phase III, prospective, randomized (1:1:1:1), factorial design 2x2, active control, and multicentre clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Angiolite and abbreviated DAPT | Experimental | Device: Angiolite: Sirolimus-eluting stent, Drug: 1-month DAPTAcute coronary syndrome patients: * Need for OAC: TAT + OAC for one week. Double therapy composed of clopidogrel + OAC up to 6 months. * No need for OAC: DAPT with acetylsalicylic acid + prasugrel or ticagrelor for 1M. Only the same P2Y12 inhibitor up to 12M. Chronic coronary syndrome patients: * Need for OAC: TAT + clopidogrel + OAC for one week. Double therapy composed of clopidogrel + OAC up to 6M. * No need for OAC: DAPT with acetylsalicylic acid + clopidogrel for one month. Only clopidogrel up to 12M. |
| Xience stent family and abbreviated DAPT | Experimental | Device: Xience: Everolimus-eluting stent, Drug: 1-month DAPTAcute coronary syndrome patients: * Need for OAC: TAT + OAC for one week. Double therapy composed of clopidogrel + OAC up to 6M. * No need for OAC: DAPT with acetylsalicylic acid + prasugrel or ticagrelor for 1 month. Only the same P2Y12 inhibitor up to 12M. Chronic coronary syndrome patients: * Need for OAC: TAT + clopidogrel + OAC for one week. Double therapy composed of clopidogrel + OAC up to 6M. * No need for OAC: DAPT with acetylsalicylic acid + clopidogrel for one month. Only clopidogrel up to 12M. |
| Angiolite and standard of care DAPT | Active comparator | Device: Angiolite: Sirolimus-eluting stent, Drug: 12-month DAPT (Standard of care)Acute coronary syndrome patients: * Need for OAC: Recommendations of the current ESC guideline: 1M of TAT (acetylsalicylic acid + clopidogrel + OAC). Dual therapy (acetylsalicylic acid or clopidogrel + OAC) up to 12M. If ischemic concerns prevail, TAT can be extended up to 6M and dual therapy up to 12M. * No need for OAC: Recommendations of the current ESC guideline: DAPT with acetylsalicylic acid and prasugrel or ticagrelor is recommended up to 12M. Chronic coronary syndrome: * Need for OAC: Recommendations of the current ESC guidelines: 1M of TAT (acetylsalicylic acid + clopidogrel + OAC). Dual therapy (acetylsalicylic acid or clopidogrel + OAC) up to 12M. If ischemic concerns prevail, TAT can be extended up to 6M and dual therapy up to 12M. * No need for OAC: Recommendations of the current ESC guidelines: DAPT composed of acetylsalicylic acid + clopidogrel up to 6M. Then, continue with acetylsalicylic acid. |
| Xience stent family and standard of care DAPT | Active comparator | Device: Xience: Everolimus-eluting stent, Drug: 12-month DAPT (Standard of care)Acute coronary syndrome patients: * Need for OAC: Recommendations of the current ESC guideline: 1M of TAT (acetylsalicylic acid + clopidogrel + OAC). Dual therapy (acetylsalicylic acid or clopidogrel + OAC) up to 12M. If ischemic concerns prevail, TAT can be extended up to 6M and dual therapy up to 12M. * No need for OAC: Recommendations of the current ESC guideline: DAPT with acetylsalicylic acid and prasugrel or ticagrelor is recommended up to 12M. Chronic coronary syndrome: * Need for OAC: Recommendations of the current ESC guidelines: 1M of TAT (acetylsalicylic acid + clopidogrel + OAC). Dual therapy (acetylsalicylic acid or clopidogrel + OAC) up to 12M. If ischemic concerns prevail, TAT can be extended up to 6M and dual therapy up to 12M. * No need for OAC: Recommendations of the current ESC guidelines: DAPT composed of acetylsalicylic acid + clopidogrel up to 6M. Then, continue with acetylsalicylic acid. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 - < 95 years;
- Presence of one or more coronary artery stenosis of 50% or more in a native coronary artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation. The vessel should have a reference vessel diameter of at least 2.00 mm (no limitation on the number of treated lesions, vessels, or lesion length);
- Able to provide informed consent and willing to participate in the trial.
Key exclusion criteria (10 listed)
- Known intolerance to acetylsalicylic acid, P2Y12 inhibitors (clopidogrel, prasugrel, or ticagrelor), sirolimus, everolimus, or chromium-cobalt.;
- Known severe hepatic impairment Child-Pug stage C;
- Prior PCI (not related to the study) performed in the last 45 days;
- Planned non-cardiac surgery during the first month after PCI, unless dual antiplatelet therapy is maintained throughout the peri-surgical period;
- Planned coronary artery bypass graft (CABG) or any other cardiac surgery (valvular for instance) following index PCI;
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 |
|---|---|---|
| Angiolite: Sirolimus-eluting stentAlso: iVascular angioliteThe angiolite stent (iVascular, Barcelona, Spain) is a thin-strut cobalt-chromium sirolimus-eluting stent with an open-cell design containing a durable biostable coating composed of three layers - acrylate to ensure adhesion to the metal surface, fluoroacrylate that carries the sirolimus, and a top layer of fluoroacrylate to control drug release. | Device | Angiolite and abbreviated DAPT, Angiolite and standard of care DAPT |
| Xience: Everolimus-eluting stentAlso: Xience stent familyThe Xience stent family (Abbott vascular, California, United States of America), characterized by an L-605 cobalt-chromium (CoCr) is a thin-strut cobalt-chromium everolimus-eluting stent with an open-cell design containing a nonerodable polymer made of PBMA, a reservoir made of a fluorinated copolymer of vinylidene fluoride and hexafluoropropylene monomers. Xience™ stent family includes XIENCE Skypoint™ and XIENCE Sierra™ | Device | Xience stent family and abbreviated DAPT, Xience stent family and standard of care DAPT |
| 1-month DAPTDAPT with acetylsalicylic acid + prasugrel or ticagrelor for 1 month. Then, only the same oral P2Y12 inhibitor (clopidogrel, prasugrel, and ticagrelor) up to 12 months. The type of agent and treatment duration will be selected according to the clinical characteristic of the patient: Acute coronary syndrome or Chronic coronary syndrome and Need for OAC or No need for OAC | Drug | Angiolite and abbreviated DAPT, Xience stent family and abbreviated DAPT |
| 12-month DAPT (Standard of care)DAPT with acetylsalicylic acid and prasugrel or ticagrelor up to 12 months. The type of agent and treatment duration will be selected according to the clinical characteristic of the patient: Acute coronary syndrome or Chronic coronary syndrome and Need for OAC or No need for OAC | Drug | Angiolite and standard of care DAPT, Xience stent family and standard of care DAPT |
Primary outcome
To determine the rate of target lesion failure between angiolite stent and Xience stent family (tested for non-inferiority) in both the standard of care DAPT regimen and abbreviated antiplatelet therapy group.
Time frame: 1 year
To determine the rate of clinically relevant bleeding events (BARC 2, 3, or 5) between an abbreviated DAPT regimen and the standard of care DAPT (tested for superiority of the experimental arm).
Time frame: 1 year
2 secondary outcomes
To determine the rate of adverse ischemic events between an abbreviated dual antiplatelet therapy regimen and the standard of care dual antiplatelet therapy (tested for non-inferiority).
Time frame: 1 year
Rate of target lesion failure between angiolite stent and Xience stent family (Skypoint or Sierra) (tested for non-inferiority) in the standard of care subgroup.
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
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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.
Manel Sabaté principal investigator
Hospital Universitari de Bellvitge
38 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Angiolite: Sirolimus-eluting stent, Xience: Everolimus-eluting stent and 1-month DAPT in people with Coronary Artery Disease, run by iVascular S.L.U. at 38 sites in 3 countries.
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 10 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: under way, not looking for participants, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in Spain, Belgium, France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
To determine the rate of target lesion failure between angiolite stent and Xience stent family (tested for non-inferiority) in both the standard of care DAPT regimen and abbreviated antiplatelet therapy group. (time frame: 1 year). 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 15 May 2026.