Health Trials

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

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

Treatments tested in this trial

  • Intravascular lithotripsy
  • Balloon

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Hospital, Clermont-Ferrand

Lead sponsor

Source ClinicalTrials.gov