An observational study in PCI Patients, de Novo Coronary Lesions and Restenotic Coronary Lesions, sponsored by iVascular S.L.U.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by iVascular S.L.U. · Observational
Prospective, multi-center, all comers, post market clinical follow-up (PMCF) registry.
To evaluate the safety and effectiveness of the Angiolite™ DES through assessment of Target Lesion Failure (TLF) at 1 year following index PCI for 5,000 patients and yearly until 5 years for the first 1,000 patients enrolled.
71 studies on the registry are indexed under Coronary Occlusion; 11 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 700 across 26 observational studies indexed under Coronary Occlusion.
Browse Coronary Occlusion studies →iVascular S.L.U. is the lead sponsor of 14 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
France
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Implantation of Angiolite DES in PCI
Target Lesion Failure (TLF)
TLF defined according to ARC-2 as the composite of cardiovascular death (CVD) target vessel myocardial infarction (TV-MI) and clinically driven (CD) target lesion revascularization (TLR) at 1-year.
Time frame: 1 year
Target Vessel Failure
TVF as composite of CVD, TV-MI, Target vessel revascularization (TVR)
Time frame: 1 year
Target Lesion Failure
TLF as composite of CVD, TV-MI, CD TLR at 2, 3, 4 and 5 years based on the data from the first 1,000 patients.
Time frame: 2, 3, 4 and 5 years
Patient Oriented Composite endpoint
(POCE), composite of any death, any MI and any coronary artery revascularization
Time frame: 1 year
Rate of Periprocedural Myocardial Infarction
Percentage of participants with periprocedural myocardial infarction (MI) related to the index PCI procedure, defined according to the Academic Research Consortium-2 (ARC-2) criteria: in patients with normal baseline cardiac troponin (cTn), a post-procedural rise in cTn ≥35 times the 99th percentile upper reference limit (URL), plus at least one of the following: new pathological Q waves, angiographic evidence of a flow-limiting complication (e.g., loss of patency of a major epicardial vessel or side branch, persistent slow flow/no-reflow, embolization), or imaging evidence of new loss of viable myocardium. In patients with elevated baseline cTn, a further rise of \>20% with an absolute post-procedural value ≥35× URL is required. Cardiac troponin is measured at baseline and at 6 and 24 hours post-procedure
Time frame: Within 48 hours after the index procedure
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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