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

Status

Indicates the current recruitment status or the expanded access status.
Approved for marketing

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
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

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Eligibility Criteria

Eligibility Criteria

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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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Changi General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Steven Kum, MBBS, Changi General Hospital

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2017

Study Registration Dates

First Submitted

First Submitted

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February 16, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CG12Aug02-12

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