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Optimal Strategy to Correct Stent underexpAnsion in Resistant Lesions

ConditionsCoronary AngioplastyRestenosisLithotripsyRestenosis of Coronary Artery StentAngioplasty, Transluminal, Percutaneous CoronaryPercutaneous Coronary Intervention (PCI)OCT AngiographyOptical Coherence Tomography (OCT)Intravascular Lithotripsy; Rotational Atherectomy; OFDIIntravascular LithotripsyCoronary Artery DiseaseCoronary Artery Disease (CAD)Coronary Stent Restenosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Clermont-Ferrand

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intravascular lithotripsy

    Procedure/Surgery

    ISR with UE will be treated by intravascular lithotripsy

  • Balloon

    Procedure/Surgery

    ISR with UE will be treated with non compliant balloons, very high-pressure balloons, cutting balloons

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Intravascular lithotripsyExperimental treatment 1 intervention
Group B: BalloonActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Post PCI Stent expansion

Minimal stent area (MSA)/average reference vessel area

Time frame
At enrollment

Secondary outcomes

1

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.

Time frame
At enrollment
2

Successful lithotripsy catheter delivery

Number of patients with successful lithotripsy catheter delivery

Time frame
At enrollment
3

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).

Time frame
Day 1 - Day 7
4

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)

Time frame
Day 1- Day 7

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Clermont-Ferrand

Lead sponsor

Source ClinicalTrials.gov
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