NCT06813534

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
14mo left

Started Aug 2024

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Aug 2024Aug 2027

First Submitted

Initial submission to the registry

May 9, 2023

Completed
1.3 years until next milestone

Study Start

First participant enrolled

August 8, 2024

Completed
6 months until next milestone

First Posted

Study publicly available on registry

February 7, 2025

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2027

Expected
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2027

Last Updated

February 7, 2025

Status Verified

February 1, 2025

Enrollment Period

2.9 years

First QC Date

May 9, 2023

Last Update Submit

February 3, 2025

Conditions

Coronary Artery Disease

Keywords

Coronary artery diseasechronic kidney diseaseContrast induced nephropathyIVUS

Outcome Measures

Primary Outcomes (1)

  • Rate of serum creatinine due to nephropathy

    Contrast-induced nephropathy is defined as an increase in creatininemia by 25% from its baseline level. The parameter being measured is creatininemia, which refers to the concentration of creatinine in the blood. The unit of measurement for this increase is a percentage (%)

    30 days

Secondary Outcomes (11)

  • Global safety

    30 days

  • Endocoronary complications

    72 hours

  • Procedural Criteria

    72 hours

  • Myocardial infarction

    30 days

  • Global safety : stroke

    30 days

  • +6 more secondary outcomes

Study Arms (2)

Conventionnal PCI

ACTIVE COMPARATOR

Contrast guided PCI

Device: Intravascular Ultrasound guided PCI

IVUS guided PCI

EXPERIMENTAL

IVUS guided PCI with iodine contrast injection limited (as much as possible) to a final control injection.

Device: Intravascular Ultrasound guided PCI

Interventions

Intravascular Ultrasound guided PCIDEVICE

Intra-coronary ultrasound

Conventionnal PCIIVUS guided PCI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Iodine contrast injection in the previous 72 hours
  • Known allergy to iodine contrast
  • Permanent dialysis
  • Chronic total occlusion
  • Hemodynamic instability
  • Legal protection
  • Pregnant of breastfeeding patients
  • Patients on "AME"

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Romain GALLET

Créteil, Creteil, 94010, France

NOT YET RECRUITING

Romain GALLET

Créteil, 94010, France

RECRUITING

MeSH Terms

Conditions

Coronary Artery DiseaseRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Romain GALLET, Pr

CONTACT

01 49 81 21 11romain.gallet@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants are assigned to one of two or more groups in parallel for the duration of the study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2023

First Posted

February 7, 2025

Study Start

August 8, 2024

Primary Completion (Estimated)

July 7, 2027

Study Completion (Estimated)

August 4, 2027

Last Updated

February 7, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION

Locations

FR(2)