Intravascular Ultrasound in Patients With End-stage Renal Disease on Dialysis (IVUS in ESRD)
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|ClinicalTrials.gov Identifier: NCT04399941|
Recruitment Status : Not yet recruiting
First Posted : May 22, 2020
Last Update Posted : May 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|End Stage Renal Disease||Diagnostic Test: Venography Diagnostic Test: Intravascular ultrasound (IVUS) Other: Image processing||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Role of Intravascular Ultrasound in Patients With End-stage Renal Disease on Dialysis|
|Estimated Study Start Date :||July 2020|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||September 2022|
Experimental: IVUS and venography group
Participants in the this group will receive venography/fistulogram, intravascular ultrasound (IVUS), and image processing.
Diagnostic Test: Venography
The venography will be performed as part of the patient's standard of care. The dialysis access will be punctured upstream of the arteriovenous anastomosis in AVF or AVG using a 4-F coaxial access set (Micro- puncture; Cook, Inc, Bloomington, Indiana). The contrast will be injected intravenously by a pump with 200 psi and a bolus of 2m/sec for total of 5 ml during upper extremity vein filming and 10 ml of contrast bolus by 3 ml/s during central vein filming while holding the breath in inspiration in anterioposterior plane.
Other Name: Fistulogram
Diagnostic Test: Intravascular ultrasound (IVUS)
IVUS will be performed through the same sheath of the coaxial access set using an Eagle Eye Platinum RX digital catheter 7F over a compatible guidewire under fluoroscopic guidance. The lesion will be estimated fluoroscopically from the marker IVUS catheter in the vein and the cranial and caudal margins of stenotic lesion will be directly visualized during pullback of the IVUS catheter.
Other: Image processing
Image processing will be performed by two radiologists in a blinded manner on the images devoid of personal identifier. An adjudication committee will oversee the process and confirm their findings in case of a discrepancy.
- Extent of stenosis [ Time Frame: 18 months ]The severity of venous stenosis will be assessed using venogram and IVUS results. It will be calculated as the percentage diameter or area reduction, expressed as the ratio of the MLD or MLA to the RVD or RVA.
- Length of lesions [ Time Frame: 18 months ]The length of each lesion will be measured between points with >50% diameter reduction in comparison to the referenced vein diameter and the referenced vein area at the pre-stenotic venous segment.
- Morphology of lesion [ Time Frame: 18 months ]The morphology of lesion will be defined as fibrotic and fibrofatty based on IVUS images.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04399941
|Contact: Vipul Chitalia, MD PhD||617 638 firstname.lastname@example.org|
|United States, Massachusetts|
|Boston Medical Center|
|Boston, Massachusetts, United States, 02118|
|Contact: Vipul Chitalia, MD PhD email@example.com|
|Principal Investigator:||Vipul Chitalia, MD PhD||Boston Medical Center|