Coronary AngioplastyOSCARNCT07316504
Optimal Strategy to Correct Stent underexpAnsion in Resistant Lesions
A study testing Intravascular lithotripsy and Balloon in people with Coronary Angioplasty and Restenosis, run by University Hospital, Clermont-Ferrand at 2 sites in France.
Trial summary
Percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) accounts for 5-10% of PCI. ISR may be linked to mechanical complications mainly under-expansion (UE), neointimal hyperplasia and/or neoatherosclerosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Angioplasty, Restenosis, Lithotripsy
- What is being tested?
- Intravascular lithotripsy and Balloon
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesFrance
- Study dates
- 22 Oct 2025to Sep 2031
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who have undergone coronary angiography with ISR, defined as ≥50% reduction of the diameter of the intrastent lumen occurring ≥ 6 months after stent implantation
- And with a suspicion of stent under-expansion on angiography, possibly assisted by a stent enhancement technique
- The reference diameter of the target vessel must be ≥2.5 mm and ≤5.0 mm.
- Coronary flow must be TIMI 3
- Ability to cross the lesion with the OCT catheter (possibly after predilatation with a balloon up to 2 mm)
- Patient affiliated to the French National Health Insurance
Who cannot join
- Heart failure with NYHA III or IV (or cardiogenic shock)
- LVEF <20%
- Chronic renal failure with clearance <30mL/mn according to CKD
- Pregnant or breast-feeding women
- Patient with a condition/comorbidity that could reduce compliance with the protocol, including pre-specified study follow-up
- Patient participating in another ongoing medical study evaluating a pharmacological or biological agent or medical device, unless authorized by the concomitant protocol.
- Patient unable to tolerate double antiaggregation (i.e., aspirin and clopidogrel or prasugrel or ticagrelor) for at least 6 months.
- Possible or defined thrombus (by angiography or endovascular imaging) in the target vessel.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Clermont Ferrand Hospital
Clermont-Ferrand, Auvergne, 63000
Géraud SOUTEYRAND, Professor, +33 4 73 75 19 90 ext. 62308, gsouteyrand@chu-clermontferrand.fr
- Not yet recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Lise Laclautre, +33473754963, promo_interne_drci@chu-clermontferrand.fr
Géraud Souteyrand
About this study
Percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) accounts for 5-10% of PCI. ISR may be linked to mechanical complications mainly under-expansion (UE), neointimal hyperplasia and/or neoatherosclerosis. International guidelines recommends non-compliant and very-high-pressure balloons, which lead to sub-optimal angiographic and clinical results. Recently, observational studies have suggested the feasibility and safety of intravascular lithotripsy (IVL) in UE treatment. There are no prospective randomised controlled studies comparing intravascular lithotripsy with balloons in ISR with UE.
Read the detailed description
In-stent restenosis (ISR) angioplasties account for between 5 and 10% of Percutaneous coronary intervention (PCI). Several mechanisms are causing RIS, including neointimal hyperplasia, neoatherosclerosis, and/or mechanical complications, mainly stent under-expansion. In addition, the calcified lesions associated with stent under-expansion are under-diagnosed in angiography as shown by intra-coronary imaging studies. The stent under-expansion is defined as a ratio between the minimum intrastent surface area and the average vessel lumen of <80%. Currently, the management of these lesions is not codified and consists empirically of the use of non-compliant balloons, cutting balloons, and/or very high-pressure balloons. These treatments result in suboptimal angiographic results, with clinical consequences in terms of revascularization recurrence (angina, unstable angina, and in 25% of cases, acute coronary syndrome).
A growing interest in intravascular lithotripsy (IVL) use to treat these calcified lesions with stent underexpansion appears as an appealing option for a safe procedure but without robust data on efficacy. Furthermore, guidelines published in 2020 by the expert consensus of the EAPCI (European Association of Percutaneous Coronary Interventions) classified IVL among the therapeutic strategy indicated in stent under-expansion with calcified lesions. The OSCAR study is a randomized, controlled, multicenter trial investigating the use of IVL compared to other standard strategies in the treatment of in-stent restenosis with under-expansion.
- Conditions
- Coronary Angioplasty, Restenosis, Lithotripsy, Restenosis of Coronary Artery Stent, Angioplasty, Transluminal, Percutaneous Coronary, Percutaneous Coronary Intervention (PCI)
- Being tested
- Intravascular lithotripsy, Balloon
- Keywords
- restenosis, underexpansion, intrastent restenosis, randomized clinical trial, intravascular lithotripsy, baloon PCI, 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.
Intravascular lithotripsyProcedure or surgery
ISR with UE will be treated by intravascular lithotripsy
BalloonProcedure or surgery
ISR with UE will be treated with non compliant balloons, very high-pressure balloons, cutting balloons
| Study group | Role | What they receive |
|---|---|---|
| Intravascular lithotripsy | Experimental | ISR with UE will be treated by intravascular lithotripsy Receives: Procedure: Intravascular lithotripsy |
| Balloon | Active comparator | ISR with UE will be treated with non compliant balloons, very high-pressure balloons, cutting balloons Receives: Procedure: Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post PCI Stent expansion
Minimal stent area (MSA)/average reference vessel area
Measured: At enrollment
Secondary outcomes (6)
Minimal stent area >4.5mm2 or Stent expansion ≥80%
Number of patients with Efficiency (yes/no) Efficiency defined by: optimal stent expansion (Minimal Stent Area [MSA]/mean reference vessel diameter ≥ 80%) and/or MSA > 4.5 mm².
Measured: At enrollment
Successful lithotripsy catheter delivery
Number of patients with successful lithotripsy catheter delivery
Measured: At enrollment
Procedural success evaluated by the occurence of the clinical events below
Procedural success is defined as residual stenosis < 50% or MSA > 4.5 mm2 and no angiographic complications (i.e., acute dissection (types B to F), perforation, acute vessel obstruction, persistent slow flow, or no reflow) or distal embolization.
- Residual stenosis < 50% post-procedure (assessed by Quantitative Coronary Angiography (QCA))
- No significant stent malapposition
- Target lesion failure defined as: cardiac death, myocardial infarction (unless clearly attributable to a vessel other than the target vessel) and target lesion revascularization (TLR) during index hospitalization (Day 1-Day 7).
- Target Vessel Failure (TVF) defined as: cardiac death, myocardial infarction (unless clearly attributable to a vessel other than the target vessel) and target vessel revascularization (TVR) during index hospitalization (Day 1-Day 7).
Measured: Day 1 - Day 7
Peri-procedural complications evaluated by the occurence of the clinical events below
- Coronary arteries: Dissection (A-F), persistent slow flow, no reflow, perforation, embolization, acute vessel occlusion, side branch occlusion (>1.5 mm, final TIMI flow)
- Peri-procedural infarction
- Vascular access complications: dissection, hematoma, pseudoaneurysm, hemorrhage
- Radiation protection parameters: procedure time (min), air kerma, total dose-area product (DAP), iodine quantity (ml)
Measured: Day 1- Day 7
Safety criteria evaluated by the occurence of the clinical events below
- All-cause mortality
- Cardiovascular mortality
- Peri-procedural myocardial infarction
- Spontaneous myocardial infarction
- Probable or definite stent thrombosis
- Stroke
- Major bleeding
Measured: From enrollment to the end of study at Month 36
Efficiency criteria evaluated by any of the clinical events described below
- Target Lesion Revascularization (TLR)
- Target Vessel Revascularization (TVR)
- Target Vessel Non-Target lesion Revascularization (TV-NTLR)
- Non-Target Vessel Revascularization (NTVR)
- Any hospitalization (for cardiac reasons or related to the procedure)
Measured: From enrollment to the end of study at Month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start22 Oct 2025
- Primary completionSep 2028 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary AngioplastyStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Géraud Souteyrand, MD, PhD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07316504
- Sponsor's protocol ID
- RBHP 2025 SOUTEYRAND
- Acronym
- OSCAR
- Status last verified
- Dec 2025
- First submitted
- 5 Sep 2025
- Last updated
- 5 Jan 2026
- 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 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Strategy to Correct Stent underexpAnsion in Resistant Lesions
- ClinicalTrials.gov ID
- NCT07316504
- Acronym / sponsor ID
- OSCAR / RBHP 2025 SOUTEYRAND
- Conditions
- Coronary Angioplasty, Restenosis, Lithotripsy, Restenosis of Coronary Artery Stent, Angioplasty, Transluminal, Percutaneous Coronary, Percutaneous Coronary Intervention (PCI)
- Keywords
- restenosis, underexpansion, intrastent restenosis, randomized clinical trial, intravascular lithotripsy, baloon PCI, Percutaneous coronary intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 5 Jan 2026 (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.
Percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) accounts for 5-10% of PCI. ISR may be linked to mechanical complications mainly under-expansion (UE), neointimal hyperplasia and/or neoatherosclerosis. International guidelines recommends non-compliant and very-high-pressure balloons, which lead to sub-optimal angiographic and clinical results. Recently, observational studies have suggested the feasibility and safety of intravascular lithotripsy (IVL) in UE treatment. There are no prospective randomised controlled studies comparing intravascular lithotripsy with balloons in ISR with UE.
Detailed description
In-stent restenosis (ISR) angioplasties account for between 5 and 10% of Percutaneous coronary intervention (PCI). Several mechanisms are causing RIS, including neointimal hyperplasia, neoatherosclerosis, and/or mechanical complications, mainly stent under-expansion. In addition, the calcified lesions associated with stent under-expansion are under-diagnosed in angiography as shown by intra-coronary imaging studies. The stent under-expansion is defined as a ratio between the minimum intrastent surface area and the average vessel lumen of <80%. Currently, the management of these lesions is not codified and consists empirically of the use of non-compliant balloons, cutting balloons, and/or very high-pressure balloons. These treatments result in suboptimal angiographic results, with clinical consequences in terms of revascularization recurrence (angina, unstable angina, and in 25% of cases, acute coronary syndrome).
A growing interest in intravascular lithotripsy (IVL) use to treat these calcified lesions with stent underexpansion appears as an appealing option for a safe procedure but without robust data on efficacy. Furthermore, guidelines published in 2020 by the expert consensus of the EAPCI (European Association of Percutaneous Coronary Interventions) classified IVL among the therapeutic strategy indicated in stent under-expansion with calcified lesions. The OSCAR study is a randomized, controlled, multicenter trial investigating the use of IVL compared to other standard strategies in the treatment of in-stent restenosis with under-expansion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravascular lithotripsy | Experimental | Procedure: Intravascular lithotripsyISR with UE will be treated by intravascular lithotripsy |
| Balloon | Active comparator | Procedure: BalloonISR with UE will be treated with non compliant balloons, very high-pressure balloons, cutting balloons |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient who have undergone coronary angiography with ISR, defined as ≥50% reduction of the diameter of the intrastent lumen occurring ≥ 6 months after stent implantation
- And with a suspicion of stent under-expansion on angiography, possibly assisted by a stent enhancement technique
- The reference diameter of the target vessel must be ≥2.5 mm and ≤5.0 mm.
- Coronary flow must be TIMI 3
- Ability to cross the lesion with the OCT catheter (possibly after predilatation with a balloon up to 2 mm)
Key exclusion criteria (8 listed)
- Heart failure with NYHA III or IV (or cardiogenic shock)
- LVEF <20%
- Chronic renal failure with clearance <30mL/mn according to CKD
- Pregnant or breast-feeding women
- Patient with a condition/comorbidity that could reduce compliance with the protocol, including pre-specified study follow-up
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 |
|---|---|---|
| Intravascular lithotripsyISR with UE will be treated by intravascular lithotripsy | Procedure or surgery | Intravascular lithotripsy |
| BalloonISR with UE will be treated with non compliant balloons, very high-pressure balloons, cutting balloons | Procedure or surgery | Balloon |
Primary outcome
Post PCI Stent expansion
Time frame: At enrollment
Minimal stent area (MSA)/average reference vessel area
6 secondary outcomes
Minimal stent area >4.5mm2 or Stent expansion ≥80%
Time frame: At enrollment
Successful lithotripsy catheter delivery
Time frame: At enrollment
Procedural success evaluated by the occurence of the clinical events below
Time frame: Day 1 - Day 7
Peri-procedural complications evaluated by the occurence of the clinical events below
Time frame: Day 1- Day 7
Safety criteria evaluated by the occurence of the clinical events below
Time frame: From enrollment to the end of study at Month 36
Efficiency criteria evaluated by any of the clinical events described below
Time frame: From enrollment to the end of study at Month 36
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 5 Jan 2026.
- 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.
Géraud Souteyrand, MD, PhD principal investigator
University Hospital, Clermont-Ferrand
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravascular lithotripsy and Balloon in people with Coronary Angioplasty and Restenosis, run by University Hospital, Clermont-Ferrand at 2 sites in France.
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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in 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.
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?
Contact Lise Laclautre, Pharm.D (+33473754963, promo_interne_drci@chu-clermontferrand.Fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post PCI Stent expansion (time frame: At enrollment). 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 5 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.