PET CT analysis of restenosis after lower limb revascularisatio

Not Applicable

Completed

• Conditions: Peripheral Arterial Disease; Circulatory System

• Registration Number: ISRCTN34690731
• Lead Sponsor: British Heart Foundation

Brief Summary

2019 results in https://pubmed.ncbi.nlm.nih.gov/31202739/ (added 08/04/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-15
• Study Completion: 2018-10-01
• Last Update Posted: 27 April 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Aged 50 years or over (women aged 55 years or over)
2. Symptomatic peripheral arterial disease (intermittent claudication / critical limb ischaemia)
3. Undergoing superficial femoral artery angioplasty (PTA) or femoro-popliteal vein bypass graft (FPBG)
4. Patients with TASC A and B lesions for the PTA group (there will be no restriction with regard to disease severity on the FPBG group as long as the anastomosis is to the popliteal artery)
5. Taking standard antiplatelet/statin medication

Exclusion Criteria

1. Inability to undergo PET/CT
2. Presence of end stage renal failure
3. Metastatic malignancy
4. Patients undergoing adjunct endovascular procedures in the infrainguinal segments – PTA group only (e.g. Bare Metal Stent, Drug Eluting Balloon, Drug Eluting Stent)
5. Previous ipsilateral femoral artery angioplasty within the previous 6 months – PTA group only
6. Women under the age of 55 years
7. Patients with diabetes mellitus taking insulin

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Primary patency, defined as SFA stenosis/anastamotic stenosis of < 50%, is measured using arterial duplex scanning at 12 months<br> 2. FDG and NaF TBR measurements are measured using the scans at baseline and six weeks<br> 3. Ankle-brachial pressure index bilaterally is measured using scanning at baseline<br> 4. Blood markers and degree of disease are assessed using ultrasound duplex at baseline<br> 5. Restenosis is measured using the ultrasound duplex at 12 months<br>

Secondary Outcome Measures

Name	Time	Method
Freedom from target lesion revascularization (TLR) at 1 year is measured by arterial duplex at 12 months.