Loading clinical trials...
Loading clinical trials...
Evaluation of the 6-month Response Rate According to Two Surgical Techniques (Rotational Atherectomy vs. Angioplasty) to Treat Stenosis of Vascular Accesses in Hemodialysis. A Single-center, Randomized, Single-blind, Superiority-controlled Pilot Study.
A well-functioning hemodialysis vascular access is a decisive factor in the survival of hemodialysis patients, who have a high mortality rate. 85% of these hemodialysis patients, are treated via an arteriovenous fistula (AVF). However, the primary patency of AVFs at 1 year is 60%, mainly due to neointimal hyperplasia developing in the drainage vein, which leads to stenosis and, if left untreated, thrombosis of the AVF. Indeed, forty percent of hemodialysis patients require re-intervention on their vascular access within the year, due to stenosis on their AVF. Transluminal angioplasty (TLA) is currently used as first-line treatment for these stenoses but TLA itself causes vascular damage, with early recurrence of the stenosis in 50% of cases at 6 months, and necessitating repeated interventions. In recent years several endovascular techniques have been developed to limit the risk of re-stenosis, none of which have produced significantly better results than simple TLA. Eliminating intimal hyperplasia using a minimally invasive endovascular technique, rather than crushing it with simple angioplasty, would improve restenosis-free survival in these patients. Today, endovascular rotational atherectomy techniques are available to improve the patency of angioplasty in the treatment of complex arterial lesions of the coronary arteries and lower limbs. The atherotome is a guide-mounted catheter with a small burr at its distal end, which resects the atheromatous plaque whereas angioplasty simply crushes it. Atherectomy is followed by drug-eluting balloon (DEB) angioplasty with paclitaxel release to limit restenosis through its anti-inflammatory and anti-proliferative activity. A few cases of rotational atherectomy for the treatment of calcified stenoses in saphenous vein coronary bypasses have been reported in the literature, with encouraging results. If AVF re-stenosis should occur, the intimal hyperplasia can be removed endovascularly, thereby limiting the risk of short-term iterative stenosis. The aim of this study was to compare the 6-month re-stenosis rate with this technique (atherectomy + drug-eluting balloon) versus standard angioplasty + drug-eluting balloon for the treatment of restenosis of hemodialysis vascular accesses.
A well-functioning hemodialysis vascular access is a decisive factor in the survival of hemodialysis patients, who have a high mortality rate. 85% of these hemodialysis patients, are treated via an arteriovenous fistula (AVF), which is currently the access offering the best results in terms of patency and infectious risk. However, the primary patency of AVFs at 1 year is 60%, mainly due to the development of neointimal hyperplasia in the drainage vein, which leads to stenosis and, if left untreated, thrombosis of the AVF. Forty percent of hemodialysis patients on AVF will therefore have at least one intervention on their vascular access within the year, due to stenosis on their AVF. Transluminal angioplasty (TLA) is currently used as first-line treatment for these stenoses. However, TLA itself causes vascular damage, with migration and myofibroblast proliferation responsible for abnormal vascular remodeling, leading to early recurrence of the stenosis in 50% of cases at 6 months, limiting the long-term functionality of these angioplasties and necessitating repeated interventions on these patients. For all these reasons, developing techniques to limit the risk of re-stenosis of hemodialysis AVFs is a public health issue. In recent years several endovascular techniques have been developed to limit the risk of re-stenosis: paclitaxel-coated "active" balloon angioplasty, bare or covered stenting, none of which have produced significantly better results than simple TLA. Eliminating intimal hyperplasia using a minimally invasive endovascular technique, rather than crushing it with simple angioplasty, would improve restenosis-free survival in these patients, without increasing the burden of management. Today, endovascular rotational atherectomy techniques are available to improve the patency of angioplasty in the treatment of complex arterial lesions of the coronary arteries and lower limbs. The atherotome is a guide-mounted catheter with a small burr at its distal end, which resects the atheromatous plaque where angioplasty simply crushes it. Atherectomy is followed by drug-eluting balloon angioplasty with paclitaxel release to limit restenosis through its anti-inflammatory and anti-proliferative activity. A few cases of rotational atherectomy for the treatment of calcified stenoses in saphenous vein coronary bypasses have been reported in the literature, with encouraging results and the absence of complications, notably perforation. If AVF re-stenosis should occur, the intimal hyperplasia can be removed endovascularly, thereby limiting the risk of short-term iterative stenosis. The aim of this study was to compare the 6-month re-stenosis rate with this technique (atherectomy + drug-eluting balloon) versus standard angioplasty + drug-eluting balloon for the treatment of restenosis of hemodialysis vascular accesses.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Start Date
March 1, 2025
Primary Completion Date
March 1, 2027
Completion Date
December 1, 2027
Last Updated
March 11, 2025
40
ESTIMATED participants
Standard angioplasty + drug-eluting balloon technique
PROCEDURE
Atherectomy + drug-eluting balloon
PROCEDURE
Lead Sponsor
Centre Hospitalier Universitaire de Nīmes
NCT04992572
NCT07477002
NCT07474935
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions