Atherectomy Clinical Trials

Clinical trials related to Atherectomy Procedure

Optimal Strategy to Correct Stent underexpAnsion in Resistant Lesions

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU de Clermont-Ferrand
NOT_YET_RECRUITING
Clermont-ferrand
Clermont Ferrand Hospital
RECRUITING
Clermont-ferrand
Contact Information
Primary
Lise Laclautre, Pharm.D
promo_interne_drci@chu-clermontferrand.Fr
+33473754963
Time Frame
Start Date: 2025-10-22
Estimated Completion Date: 2031-09
Participants
Target number of participants: 80
Treatments
Experimental: Intravascular lithotripsy
ISR with UE will be treated by intravascular lithotripsy
Active_comparator: Balloon
ISR with UE will be treated with non compliant balloons, very high-pressure balloons, cutting balloons
Sponsors
Leads: University Hospital, Clermont-Ferrand

This content was sourced from clinicaltrials.gov