Contrast-free IVUS Guided PCI Compared to Standard Angio-guided PCI in Patient With sEvere kidnEy Disease

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The incidence of contrast-induced nephropathy (CIN) is high (\> 25%) in patients with severe chronic renal disease (CKD) who undergo a percutaneous coronary procedure. The development of CIN is a factor of poor prognosis and is associated with the occurrence of irreversible CKD, the need for dialysis, increased length of stay and hospital costs as well as the risk of death. There is no specific treatment for N-PCI, so its prevention is essential. Although many studies have been conducted to identify, compare and implement different pharmacological strategies for the prevention of CIN before percutaneous coronary procedurse, few per-procedural strategies have been studied to prevent this risk. Intracoronary ultrasound (IVUS) is an essential tool, used routinely to guide percutaneous coronary procedures thanks to ultrasound, it does not require the injection of iodine contrast. The main objective is to show that an IVUS-guided zero-contrast coronary angioplasty strategy in patients with severe renal impairment decreases the incidence of CIN within 72 hours of procedure.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients over 18 years old

• Indication for PCI

• Chronic kidney disease with creatinine clearance ≤ 30 mL/min/1.73m²

• Feasibility of IVUS determined by 2 trained interventional cardiologist

• Affiliated to social security

Locations
Other Locations
France
Romain GALLET
RECRUITING
Créteil
Romain GALLET
NOT_YET_RECRUITING
Créteil
Contact Information
Primary
Romain GALLET, Pr
romain.gallet@aphp.fr
01 49 81 21 11
Time Frame
Start Date: 2024-08-08
Estimated Completion Date: 2027-08-04
Participants
Target number of participants: 170
Treatments
Active_comparator: Conventionnal PCI
Contrast guided PCI
Experimental: IVUS guided PCI
IVUS guided PCI with iodine contrast injection limited (as much as possible) to a final control injection.
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov