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NCT06813534Recruiting

IVUS Guided PCI in Patients With Chronic Kidney Disease

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

Source: ClinicalTrials.gov · Last updated 7 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
170 (estimated)
First submitted
9 May 2023
Start date
8 Aug 2024
Primary completion date
7 Jul 2027
Lead sponsor
Assistance Publique - Hôpitaux de Paris
NCT number
NCT06813534

What you commit to

  • Study type: Interventional
  • Planned participants: 170
  • From 8 Aug 2024 to the primary completion date, 7 Jul 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Iodine contrast injection in the previous 72 hours

Other illness

  • Known allergy to iodine contrast

Other

  • Permanent dialysis
  • Chronic total occlusion
  • Hemodynamic instability
  • Legal protection
  • Pregnant of breastfeeding patients
  • Patients on "AME"

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Romain GALLET
Coordinator of this site? Confirm its status
CréteilFranceNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.