NCT03891693

Biomimetic Stent and Drug Eluting Balloon to Treat Recurrent Cephalic Arch Stenosis

Biomimetic (SUPERA) Stent and Drug Eluting Balloon (Passeo 18 Lux) to Treat Recurrent Cephalic Arch Stenosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Singapore General Hospital · Academic / Other
• Sex: All
• Age: 21 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The study evaluates the use of a biomimetic stent (SUPERA®) and a drug eluting balloon (DEB - Passeo 18 Lux) for the treatment of recurrent and tight cephalic arch stenosis in patients with brachiocephalic fistulas. All participants will undergo angioplasty with stated devices, and be followed up with over 12 months.

Detailed description

To date, the treatment options are limited for recurrent and tight cephalic arch stenosis in patients with brachiocephalic fistulas - Angioplasty, with or without the placement of a stent, surgical bypass using the internal jugular vein or a cephalic/brachial venous anastomosis, or the creation of a new fistula may be a reasonable option. Angioplasty may be associated with technical failure and rupture of the arch vein in reported incidences of 24% and 6%, respectively. Percutaneous Transluminal Angioplasty (PTA) is associated with very low primary patency rates of 42% and 23% at 6 and 12 months, whilst bare stents are equally poor, with reported patency of 39% and 0% at those same time-point. The use of a biomimetic stent (SUPERA®) in the cephalic arch has not been studied to date, but may not only offer protection from rupture of the arch vein but may also create a material barrier to prevent the development of Neo-Intimal Hyperplasia (NIH). With the additional use of drug elution, this may impede NIH effect even more.

Conditions

• Brachiocephalic Vein Stenosis

Interventions

Type	Name	Description
DEVICE	Passeo-18 Lux and SUPERA® stent	Angioplasty of Arteriovenous Fistula (AVF) performed using Passeo-18 Lux and SUPERA® stent for patients with cephalic arch stenosis

Timeline

• Start date: 2018-09-05
• Primary completion: 2020-06-30
• Completion: 2021-01-30
• First posted: 2019-03-27
• Last updated: 2021-03-17

Locations

1 site across 1 country: Singapore