IVUS Guided PCI in Patients With Chronic Kidney Disease (SPEED)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Intravascular Ultrasound guided PCI

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Romain GALLET, Pr; Phone Number: 01 49 81 21 11; Email: romain.gallet@aphp.fr

Study Locations

• France
  • Créteil, France, 94010
    • Recruiting
    • Romain GALLET
    • Contact: Romain GALLET; Phone Number: 0149812111; Email: romain.gallet@aphp.fr
  • Creteil
    • Créteil, Creteil, France, 94010
      • Not yet recruiting
      • Romain GALLET
      • Contact: Romain GALLET; Phone Number: 0149812111; Email: romain.gallet@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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"

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventionnal PCI; Contrast guided PCI	Device: Intravascular Ultrasound guided PCI; Intra-coronary ultrasound
Experimental: IVUS guided PCI; IVUS guided PCI with iodine contrast injection limited (as much as possible) to a final control injection.	Device: Intravascular Ultrasound guided PCI; Intra-coronary ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global safety	The occurrence of death from any cause within 30 days. The unit of measurement is the presence or absence of death.	30 days
Endocoronary complications	his includes dissection, thrombus formation, breaches, or coronary occlusion that require an additional unplanned intervention. The unit of measurement is the occurrence of these complications, recorded as Yes or No.	72 hours
Procedural Criteria	Procedure time: The total time taken for the procedure. The unit of measurement is time, typically recorded in minutes (min)	72 hours
Myocardial infarction	The occurrence of a myocardial infarction within 30 days. The unit of measurement is the presence or absence of the event, recorded as Yes or No."	30 days
Global safety : stroke	Stroke: The occurrence of a stroke within 30 days. The unit of measurement is the presence or absence of the event, recorded as Yes or No	30 days
Global safety	Unplanned hospitalization for cardiac or renal causes: The occurrence of an unplanned hospitalization due to cardiac or renal causes within 30 days. The unit of measurement is the presence or absence of the event, recorded as Yes or No.	30 days
Angioplasty failures	Angioplasty failures are defined by a residual stenosis of 70% or greater and/or a TIMI flow of less than 3 at the end of the procedure. The unit of measurement for residual stenosis is percentage (%) and for TIMI flow, the unit is a scale from 0 to 3, with a TIMI flow of less than 3 indicating failure.	72 hours
Procedural Criteria : Fluoroscopy time	Fluoroscopy time: The amount of time fluoroscopy imaging is used during the procedure. The unit of measurement is time, typically recorded in minutes (min)	72 hours
Procedural Criteria: Air Kerma	Air Kerma: A measure of the radiation dose delivered during the procedure. The unit of measurement is the Gray (Gy), specifically milligray (mGy) for this context	72 hours
Procedural Criteria : PDS (Procedure Dose Score)	PDS (Procedure Dose Score): A measure of the total radiation dose delivered to the patient during the procedure. The unit of measurement is arbitrary units based on the specific scoring system used.	72 hours
Procedural Criteria	Volume of contrast injected: The amount of contrast material used during the procedure. The unit of measurement is milliliters (mL)	72 hours

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2024
• Primary Completion (Estimated): July 7, 2027
• Study Completion (Estimated): August 4, 2027

Study Registration Dates

• First Submitted: May 9, 2023
• First Submitted That Met QC Criteria: February 3, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Coronary artery disease; chronic kidney disease; IVUS; Contrast induced nephropathy
• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Kidney Diseases; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: APHP230196

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No