PCI PatientsiLITENCT07887230
iLITE, Clinical Performance of the Angiolite™ Drug-Eluting Stent
An observational study of PCI Patients and de Novo Coronary Lesions, run by iVascular S.L.U..
Trial summary
Prospective, multi-center, all comers, post market clinical follow-up (PMCF) registry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PCI Patients, de Novo Coronary Lesions, Restenotic Coronary Lesions
- What is being tested?
- Percutaneous Coronary Intervention
- Type of treatment
- Surgery or procedure
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Oct 2033
- Phase
- Observational
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
Study population: France
Who may be able to join
- Subject conditions compliant with the current IFU
- Age ≥18 years.
- Clinical indication for PCI according to current guidelines.
- Intended treatment with at least one commercially available Angiolite™ DES
- Ability to provide informed consent.
- Willingness to comply with follow-up requirements.
Who cannot join
- Subject has any condition listed as contraindications in the IFU
- Refusal or inability to provide informed consent.
- Life expectancy <1 year.
- Subject will be excluded if they are under judicial protection, guardianship, or curatorship
About this study
Official title: iLITE, Investigation of Mid/Long-term Clinical Performance of the Angiolite™ Drug-Eluting Stent in Contemporary Clinical Practice
Prospective, multi-center, all comers, post market clinical follow-up (PMCF) registry.
Read the detailed description
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.
- Conditions
- PCI Patients, de Novo Coronary Lesions, Restenotic Coronary Lesions, Acute Myocardial Infarction (AMI), Suspected Acute Coronary Occlusion
- Being tested
- Percutaneous Coronary Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Coronary InterventionProcedure or surgery
Implantation of Angiolite DES in PCI
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (4)
Target Vessel Failure
TVF as composite of CVD, TV-MI, Target vessel revascularization (TVR)
Measured: 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.
Measured: 2, 3, 4 and 5 years
Patient Oriented Composite endpoint
(POCE), composite of any death, any MI and any coronary artery revascularization
Measured: 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
Measured: Within 48 hours after the index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2033 (estimated)
- Study completionOct 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCI PatientsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- iVascular S.L.U.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philippe Garot, Principal investigator, Hopital Privé Jacques Cartier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07887230
- Sponsor's protocol ID
- IVF-CARDIO-01
- Acronym
- iLITE
- Status last verified
- Oct 2026
- First submitted
- 7 Sep 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided