Optimal Strategy to Correct Stent underexpAnsion in Resistant Lesions

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. 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

Inclusion criteria :

* 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

Exclusion criteria :

* 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.

Conditions14

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