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

NCT ID: NCT02686541

Last Updated: 2016-02-23

Basic Information

• Recruitment Status: APPROVED_FOR_MARKETING
• Study Classification: EXPANDED_ACCESS
• Study Start Date: 2015-04-30

Brief 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

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Symptomatic ≥ 50% stenosis or occlusions of the femoral or popliteal artery (including below knee popliteal artery) proven on 2 views during angiography of Rutherford stage 2-6 lesions
• At least one tibial vessel runoff
• Life expectancy >1 year

Exclusion Criteria

• Subintimal recanalisation of the affected de novo artery which would preclude treatment with athrectomy
• Patient unwilling or unlikely to comply with follow-up schedule
• GFR <30 ml/min
• Planned major index limb amputation
• Acute limb ischaemia
• Untreated ipsilateral iliac artery stenosis ≥ 50
• Previous atherectomy, brachytherapy or cryoplasty of the affected arterial segment
• Severe flow limiting dissection or residual stenosis >50% post initial athrectomy requiring supplementary stenting
• Female patients of childbearing potential

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changi General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Steven Kum Wei Cheong

Vascular Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven Kum, MBBS

Role: PRINCIPAL_INVESTIGATOR

Changi General Hospital

Locations

Changi General Hospital

Singapore, , Singapore

Countries

Singapore

Other Identifiers

CG12Aug02-12

Identifier Type: -

Identifier Source: org_study_id