NCT02686541

Athrectomy and Drug Eluting Balloon Therapy (ADEBT) on the Femoral Popliteal Arteries

• Status: Approved For Marketing
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Changi General Hospital · Academic / Other
• Sex: All
• Age: 21 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to study the effects of athrectomy followed by percutaneous transluminal angioplasty using Paclitaxel coated Drug Eluting Balloon (DEB) in treating de novo or re-stenotic lesions in the femoral-popliteal artery in patients with symptomatic peripheral vascular disease in an Asian population. The intention is to study the effects of debulking athrectomy followed by application of DEBs to prevent restenosis, resulting in improved patency rates The study will prospectively recruit 8 cases treated with athrectomy followed by DEB. This project is a pilot to investigate the effects of athrectomy and DEB in reducing re-stenosis rates. It will be a primer for a larger scale randomized controlled trial (RCT) involving multiple institutions to demonstrate the benefit of athrectomy and DEB technology to treat de novo versus plain balloon angioplasty with bail-out stenting, which is currently the most commonly used modality to treat femoral-popliteal lesions. There are no studies combining the effect of rotational athrectomy and DEBs.

Detailed description

Patient will undergo an intervention under anaesthesia. After common femoral artery sheath access, a diagnostic angiogram will be performed. After pre-arthrectomy Intravascular ultrasound (IVUS) of the affected arterial segment, patient will undergo treatment of the lesion with arthrectomy, followed by post-arthrectomy IVUS analysis. Following arthrectomy, the affected vessel will be treated by supplementary Ranger Drug Eluting Balloon (DEB). During post-procedure, patients will be started on dual antiplatelets for 3 months followed by Aspirin for life unless contraindicated. Clinical follow-up, duplex ultrasound (to assess for re-stenosis) and Ankle Brachial Pressure Index (ABPI) will be performed at 1-month, 6-month and 12-month post intervention. Assessment of the symptoms, pulse, and clinical patency will be performed at each visit.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	Atherectomy followed by Drug Eluting Balloon (DEB)	Patient will undergo an intervention under anaesthesia. After pre-arthrectomy Intravascular ultrasound (IVUS) of the affected arterial segment, patient will undergo treatment with Arthrectomy, followed by post-arthrectomy IVUS analysis. Following arthrectomy, the affected vessel will be treated by supplementary Ranger Drug Eluting Balloon (DEB). During post-procedure, patients will be started on dual antiplatelets for 3 month post intervention followed by Aspirin for life unless contraindicated. Clinical follow-up, duplex ultrasound (to assess for re-stenosis) and Ankle Brachial Pressure Index (ABPI) will be performed at 1-month, 6-month and 12-month. Assessment of the symptoms, pulse, and clinical patency will be performed at each visit.

Timeline

• Start date: 2015-04-01
• Primary completion: 2017-03-01
• First posted: 2016-02-19
• Last updated: 2016-02-23

Locations

1 site across 1 country: Singapore