Trial record 21 of 358 for:    Expanded Access Studies

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

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Sponsor:
Information provided by (Responsible Party):
Steven Kum Wei Cheong, Changi General Hospital
ClinicalTrials.gov Identifier:
NCT02686541
First received: February 16, 2016
Last updated: February 21, 2016
Last verified: February 2016
  Purpose
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.

Condition Intervention
Peripheral Arterial Disease
Device: Atherectomy followed by Drug Eluting Balloon (DEB)

Study Type: Expanded Access     What is Expanded Access?
Official Title: Athrectomy and Drug Eluting Balloon Therapy (ADEBT) on the Femoral Popliteal Arteries

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Further study details as provided by Changi General Hospital:

Study Start Date: April 2015
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    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.

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.
  Eligibility

Ages Eligible for Study:   21 Years to 90 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02686541

Locations
Singapore
Changi General Hospital
Singapore, Singapore, 529889
Sponsors and Collaborators
Changi General Hospital
Investigators
Principal Investigator: Steven Kum, MBBS Changi General Hospital
  More Information

Responsible Party: Steven Kum Wei Cheong, Vascular Surgeon, Changi General Hospital
ClinicalTrials.gov Identifier: NCT02686541     History of Changes
Other Study ID Numbers: CG12Aug02-12 
Study First Received: February 16, 2016
Last Updated: February 21, 2016
Health Authority: Singapore: Health Sciences Authority

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 28, 2016