NCT03068845

Arteriovenous Fistula: Conventional Angioplasty vs Drug Eluting Balloon-assisted Maturation Intervention Clinical Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Singapore General Hospital · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this randomised clinical trial is to evaluate the efficacy of drug-eluting balloon compared to conventional balloon in balloon-assisted maturation of non-maturing arteriovenous fistula in adult renal failure patients.

Detailed description

This is a single-centre study, where a total of 124 subjects with non-maturing arteriovenous fistula will be randomised (1:1) to either experimental or active comparator arm. Randomisation will be stratified by location of arteriovenous fistula (above versus below elbow). Each subject will undergo fistulogram in order to assess eligibility criteria. In the event that there is more than 1 eligible stenosis, the most severe stenosis will be considered the target (study) lesion. All other lesions will be treated in the conventional manner. No coil embolisation of collaterals will be performed in the index treatment. If the subject is allocated to the experimental arm, the target lesion will be treated with pre-dilatation with a conventional balloon before application of the drug-eluting ballon. If the subject is allocated to the active comparator arm, the target lesion will be treated with a conventional balloon. High pressure balloon angioplasty may be performed if there is poor angioplasty results (significant residual stenosis of more than 30%). All subjects will be prescribed 1 month of dual antiplatelets (aspirin and clopidogrel), followed by 5 months of aspirin. The duration of the study is 12 months. Follow up visits include: 1. Two-weekly follow up visits in the first 3 months after intervention until the patient is deemed ready for trial cannulation. 2. At 3 months after intervention to assess primary outcome. 3. At 6 months after intervention for a fistulogram 4. At 12 months after intervention for study closure.

Conditions

• Stenosis of Arteriovenous Dialysis Fistula

Interventions

Type	Name	Description
DEVICE	Drug-eluting balloon angioplasty (DEBA)	DEBA will be performed after pre-dilatation of the target lesion for subjects allocated to the experimental arm. If there is more than 1 stenosis, only the most severe stenosis will be designated the target lesion and treated according to treatment allocation. All other stenoses will be treated with conventional balloon angioplasty. High pressure balloon angioplasty may be performed if there is poor angioplasty results (significant residual stenosis of more than 30%). All patients will be started on dual antiplatelets (aspirin and clopidogrel) for 1 month after intervention, followed by 5 months of aspirin.
DEVICE	Conventional Balloon Angioplasty (CBA)	CBA will be performed for the target lesion for subjects allocated to the active comparator arm. If there is more than 1 stenosis, only the most severe stenosis will be designated the target lesion and treated according to treatment allocation. All other stenoses will be treated with conventional balloon angioplasty. High pressure balloon angioplasty may be performed if there is poor angioplasty results (significant residual stenosis of more than 30%). All patients will be started on dual antiplatelets (aspirin and clopidogrel) for 1 month after intervention, followed by 5 months of aspirin.

Timeline

• Start date: 2017-06-01
• Primary completion: 2019-06-01
• Completion: 2020-03-01
• First posted: 2017-03-03
• Last updated: 2017-04-27