A Phase 3 interventional study of Drug-eluting balloon angioplasty (DEBA) and Conventional Balloon Angioplasty (CBA) in Stenosis of Arteriovenous Dialysis Fistula, sponsored by Singapore General Hospital. Status unknown. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2017-04-27.
Sponsored by Singapore General Hospital · Phase 3, Interventional, and Treatment
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.
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:
267 studies on the registry are indexed under Arteriovenous Fistula; 44 are open to participants now.
This study's planned enrollment of 124 is above the median of 68 across 177 interventional studies indexed under Arteriovenous Fistula.
Browse Arteriovenous Fistula studies →Singapore General Hospital is the lead sponsor of 266 studies on the registry; 57 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Non-maturing upper limb arteriovenous fistula (AVF) created 6-24 weeks ago with any one of the following:
Exclusion Criteria:
After predilatation of the target lesion with conventional balloon angioplasty, a drug-eluting balloon will be inflated to an appropriate inflation pressure, but not exceeding the rated burst pressure of the balloon, for at least a minute.
Device: Drug-eluting balloon angioplasty (DEBA)
The target lesion will be dilated with a conventional angioplasty balloon to an appropriate inflation pressure, but not exceeding the rated burst pressure of the balloon, for at least a minute.
Device: Conventional Balloon Angioplasty (CBA)
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.
Also known as: Biotronik Passeo Lux 18
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.
Also known as: Biotronik Passeo
Fistula used successfully for haemodialysis (FUSH)
FUSH is met if the fistula can be used with two-needle cannulation for two-thirds or more of all dialysis runs for 1 month and if it delivers the prescribed dialysis within the prescribed time frame.
Time frame: 3 month
Target lesion anatomic success
Target lesion anatomic success is defined as \<30% residual stenosis after angioplasty.
Time frame: At the end of index procedure
Time from intervention to first successful haemodialysis with two-needle cannulation
Time from intervention to first successful haemodialysis with two-needle cannulation.
Time frame: Up to 12 months
Target lesion percent stenosis at 6-month fistulogram
Percent stenosis of target lesion at 6-month fistulogram
Time frame: At 6 months
Target lesion restenosis rate at 6-month fistulogram
The incidence of \>50% stenosis of target lesion at 6-month fistulogram
Time frame: At 6 months
Number of repeat interventions to target lesion at 6 months
Number of repeat interventions to target lesion at 6 months
Time frame: At 6 months
Number of repeat interventions to target lesion at 12 months
Number of repeat interventions to target lesion at 12 months
Time frame: At 12 months
Number of repeat interventions to access circuit at 6 months
Number of repeat interventions to access circuit at 6 months
Time frame: At 6 months
Number of repeat interventions to access circuit at 12 months
Number of repeat interventions to access circuit at 12 months
Time frame: At 12 months
Post intervention target lesion patency
Interval from intervention to repeat clinically driven intervention to target lesion
Time frame: Up to 12 months
Post intervention access circuit primary patency
Primary patency is defined as the interval from balloon angioplasty until the next access thrombosis or repeated intervention to maintain access function, or until access abandonment if no interval intervention. It ends with treatment of a lesion anywhere within the access circuit, from the arterial inflow to the superior vena cava-right atrial junction.
Time frame: Up to 12 months
Post intervention access circuit assisted primary patency
Primary assisted patency is defined as the interval from balloon angioplasty until access thrombosis or a surgical intervention that excludes the treated lesion from the access circuit. Examples include percutaneous treatments of either restenosis/occlusion of the previously treated lesion or a new arterial or venous outflow stenosis/occlusion (excluding access thrombosis). It ends with percutaneous thrombolysis/thrombectomy or simple surgical thrombectomy.
Time frame: Up to 12 months
Post-intervention access circuit secondary patency
Secondary patency is defined as the interval after balloon angioplasty until the access is surgically declotted, revised or abandoned because of inability to treat the original lesion, choice of surgeon, transplant, loss to follow-up, etc. Examples include thrombolysis and percutaneous thrombectomy, as well as multiple repetitive treatments.
Time frame: Up to 12 months
Complication rates
Complications will be classified according to the Society of Interventional Radiology Standards of Practice Committee.
Time frame: At 12 months
No study locations are listed for this record.
Plan to share: No
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Singapore General Hospital