Clinical trial NCT05360394: A Prospective, Randomized Controlled Trial of Stent Graft and Drug Coated Balloon Treatment for Recurrent Cephalic Arch Stenosis in Dysfunctional Arteriovenous-venous Fistula
Official title: A Prospective, Randomized Controlled Trial of Stent Graft and Drug Coated Balloon Treatment for Recurrent Cephalic Arch Stenosis in Dysfunctional Arteriovenous-venous Fistula
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neointimal Hyperplasia
Dialysis Access Malfunction
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Arteriovenous Fistula (AVF) is a surgically created circuit used for hemodialysis in patient with End Stage Renal Disease (ESRD). A functioning dialysis vascular access is critical to the delivery of life-saving hemodialysis (HD) treatment for these patients. Unfortunately, neointimal hyperplasia frequently occurs within the dialysis vascular access, resulting in stenosis, poor flow and thrombosis with loss of function.

The cephalic vein forms the outflow conduit for radiocephalic (RC) and brachiocephalic (BC) AVF. At the perpendicular portion of the cephalic vein, the cephalic arch is often prone to developing hemodynamically significant stenosis. The prevalence of cephalic arch stenosis is reported to be 39% in brachiocepahlic and 2% in radiocephalic AVF.

The current gold standard therapy for treatment of AVF stenosis is plain balloon angioplasty (BA). Paclitaxel coated balloon (PCB) angioplasty has also been shown recently to be superior to plain BA in the treatment of stenosis in dialysis vascular access. By releasing paclitaxel, which is an anti-proliferation drug, locally into the vessel wall during balloon contact, it will blunt the acceleration of intimal hyperplasia response, resulting in improved primary patency after angioplasty.

The use of stent grafts for recurrent CAS has been demonstrated to increase patency of AVF compared to BA and bare stents. However, stent grafts are prone to edge restenosis that tend to occur within 5mm of each end of SG due to neointimal hyperplasia from the end of the stent migrating towards the center. We postulate that stent graft with PCB angioplasty of the stent edge is more effective than PCB alone in maintaining the patency of AVF with cephalic arch stenosis.

Therefore, we aim to perform a randomized controlled trial to compare the 6-month unassisted patency rate of treatment of recurrent CAS with stent graft and PCB angioplasty of both stent edge versus PCB alone.


Eligibility criteria: Inclusion Criteria:

* Age 21 - 90 years
* Patients who requires balloon angioplasty for dysfunctional arteriovenous fistula, can be de novo lesions or recurrent CAS stenosis within six months of interventions. Suitability will be determined with a baseline ultrasound assessment.
* Matured AVF, defined as being in use for at least 1 month prior to angioplasty
* Successful angioplasty of the underlying stenosis, defined as less than 30% residual stenosis on Digital Subtraction Angiography (DSA).

Exclusion Criteria:

* Patient unable to provide informed consent
* Thrombosed or partially thrombosed AVF
* Immature AVF
* Insignificant CAS defined as \<50% stenosis and no clinical indicator such as high V pressure.
* Presence of central vein stenosis with more than 30% residual stenosis post-angioplasty
* Patient who had underwent stent placement within the CAS previously
* Patients who are allergic to both aspirin or clopidogrel
* Patient who are currently enrolled in other drug eluting balloon trials
* Sepsis or active infection
* Recent intracranial bleed or gastrointestinal bleed within the past 12 months.
* Allergy to iodinated contrast media, heparin or paclitaxel
* Pregnancy

Primary outcomes:
measure: Primary Patency of Target Lesion (Cepahlic Arch)
timeFrame: 6-months post-op
measure: Primary Patency of Access Circuit
timeFrame: 6-months post-op
Secondary outcomes:
measure: Primary Patency of Target Lesion
timeFrame: 3 and 12 months post-op
measure: Primary Patency of Access Circuit
timeFrame: 3 and 12 months post-op
measure: Assisted Primary Patency of Target Lesion
timeFrame: 3 and 12 months post-op
measure: Assisted Primary Patency of Access Circuit
timeFrame: 3 and 12 months post-op
measure: Secondary Patency
timeFrame: 3 and 12 months post-op
measure: Time taken to next intervention
timeFrame: 12-months post-op
measure: Number of repeat interventions to target lesion
timeFrame: 6 and 12 months post-op
measure: Number of repeat interventions to maintain access circuit
timeFrame: 6 and 12 months post-op
measure: Rate of late lumen loss of the cephalic arch, proximal and distal stent edge
timeFrame: 12 months post-op
measure: Complication Rate
timeFrame: 1, 3, 6 and 12 months post-op
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Flinders Medical Center
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Singapore General Hospital
name: Tang Tjun Yip
role: PRINCIPAL_INVESTIGATOR
affiliation: Singapore General Hospital
name: Tan Ru Yu
role: PRINCIPAL_INVESTIGATOR
affiliation: Singapore General Hospital
name: Tay Kiang Hiong
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Shemesh D, Goldin I, Zaghal I, Berlowitz D, Raveh D, Olsha O. Angioplasty with stent graft versus bare stent for recurrent cephalic arch stenosis in autogenous arteriovenous access for hemodialysis: a prospective randomized clinical trial. J Vasc Surg. 2008 Dec;48(6):1524-31, 1531.e1-2. doi: 10.1016/j.jvs.2008.07.071. Epub 2008 Oct 1.
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