A Phase 3 interventional study of Angiolite: Sirolimus-eluting stent and Xience: Everolimus-eluting stent in Coronary Artery Disease, sponsored by iVascular S.L.U.. Active, not recruiting at 38 sites in 3 countries. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2026-05-15.
Sponsored by iVascular S.L.U. · Phase 3, Interventional, and Treatment
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Among 208 studies in Coronary Artery Disease with a site in Spain — 39 open to participants now, 66 under way, 6 of them phase 3. Coronary Artery Disease · Spain.
Among the 208 studies in Coronary Artery Disease with a site in Spain, this one is the 24th largest by enrollment of the 136 interventional ones that give a count, is one of 14 that started in 2023, is one of 22 in phase 3, reaches primary completion later than 35 of the 65 other live ones, and was the 172nd registered.
4,862 studies on the registry are indexed under Coronary Artery Disease; 893 are open to participants now.
Browse Coronary Artery Disease studies →39 of the 208 studies in Coronary Artery Disease with a site in Spain are open now. Recruiting first, the newest first:
Kristian Rivera · Sites in Spain, Mexico
Ages 18+
Ceric Sàrl · Sites in Spain
Ages 18+
Fundación EPIC · Sites in Spain
Ages 18+
Shunmei Medical · Sites in Spain, France, Germany and 1 more country
Ages 18+
Fundación EPIC · Sites in Spain, United States, Belgium and 1 more country
Ages 18–85
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 589 Coronary Artery Disease studies recruiting now, 403 (68%) set no upper age limit and 68 (12%) stop at 75 or younger; 38 take children under 18; 48 take healthy volunteers.
This study: 18 Years to 95 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
208 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 8 · Phase 3 25 · Phase 4 20
First in 1999; this study’s year is marked. 14 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 2,312 is above the median of 124 across 3,009 interventional studies indexed under Coronary Artery Disease.
Median enrollment 347 across the 136 interventional studies, 500 across the 72 observational. Of the 110 that completed or were terminated, 30 (27%) have results posted.
This tab as a report to print or save as PDF → With an account.
103 of 208 have an industry lead sponsor. The 10 most frequent:
iVascular S.L.U. is the lead sponsor of 14 studies on the registry; 7 are open to participants now.
iVascular S.L.U. has 1 study filed under Coronary Artery Disease — fewer than ten, so there is no comparison to draw.
21 of the studies in Coronary Artery Disease with a site in Spain that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05952206Phase 3iVascular S.L.U.Ischemic and Bleeding Outcomes After Angiolite Stent Implantation and an Abbreviated Dual Antiplatelet Therapy | 2027-01-13 |
| NCT06977295Instituto de Investigación Biomédica de SalamancaEvaluation of a Diagnostic Software for Coronary Artery Disease Using Retrospective CCTA Data (CODEX-1 Study) | 2026-11-30 |
| NCT05788432Fundación EPICSequent Extended Study | 2026-12-01 |
| NCT06448637Fundación EPICDRUG RELEASING BALL vs. PHARMACOACTIVE STENT IN LARGE VESSELS: MORPHOLOGICAL ANALYSIS AND FUNCTION VASOMOTOR (DEBORA STUDY) IN LARGE VESSELS: MORPHOLOGICAL ANALYSIS AND FUNCTION VASOMOTOR (DEBORA STUDY) | 2026-12-01 |
| NCT05617599Fundación EPICSUPRAFLEX CRUZ PMCF Study ( rEpic05 ) | 2026-12-01 |
Add all 21 to your calendar (.ics) → With an account.
Among the 208 studies in Coronary Artery Disease with a site in Spain, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Angiolite: Sirolimus-eluting stent · Drug: 1-month DAPT
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.
Device: Xience: Everolimus-eluting stent · Drug: 1-month DAPT
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.
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.
Device: Xience: Everolimus-eluting stent · Drug: 12-month DAPT (Standard of care)
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.
Also known as: iVascular angiolite
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™
Also known as: Xience stent family
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
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
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
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
To determine the rate of Patient-Oriented Composite endpoint
Time frame: 1-2-3-4-5 years
To determine the rate of individual components of All cause, cardiovascular, and cardiac death
Time frame: 1-2-3-4-5 years
To determine the rate of recurrent myocardial infarction
Time frame: 1-2-3-4-5 years
To determine the rate of target lesion revascularization
Time frame: 1-2-3-4-5 years
To determine the rate of target vessel revascularization
Time frame: 1-2-3-4-5 years
To determine the rate of stent thrombosis
Time frame: 1-2-3-4-5 years
To determine the rate of clinical device success
Time frame: Immediatly after the procedure
To determine the rate of clinical procedural success
Time frame: Immediatly after the procedure
To determine the rate of bleeding events
Time frame: 1-2-3-4-5 years
To determine the rate of net adverse clinical endpoints (NACE)
Time frame: 1-2-3-4-5 years
To determine the rate of major adverse cardiac and cerebral events (MACCE)
Time frame: 1-2-3-4-5 years
To determine the rate of transfusion rates
Time frame: 1-2-3-4-5 years
To determine the rate of clinically relevant bleeding events (BARC 2, 3, or 5) at 1 year between an abbreviated dual antiplatelet therapy regimen and the standard of care dual antiplatelet therapy in the female population of the study
Time frame: 1 year
To determine the rate of adverse ischemic events at 1 year between an abbreviated dual antiplatelet therapy regimen and the standard of care dual antiplatelet therapy in the female population of the study
Time frame: 1 year
Started Oct 2023 (actual). Primary completion is estimated for Jan 2027, 39 months after the start.
Of 29 industry-sponsored phase 3 interventional studies under Coronary Artery Disease, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 55. This study's planned 39 months is below that.
Counting every sponsor, half of 61 studies reached it within 47 months; a quarter within 20 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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