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

February 21, 2016 updated by: Steven Kum Wei Cheong, Changi General Hospital
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.

Study Overview

Status

Approved for marketing

Conditions

Intervention / Treatment

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.

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 529889
        • Changi General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changi General Hospital

Investigators

  • Principal Investigator: Steven Kum, MBBS, Changi General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (ANTICIPATED)

March 1, 2017

Study Registration Dates

First Submitted

February 16, 2016

First Submitted That Met QC Criteria

February 16, 2016

First Posted (ESTIMATE)

February 19, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

February 23, 2016

Last Update Submitted That Met QC Criteria

February 21, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CG12Aug02-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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