PET CT analysis of restenosis after lower limb revascularisation

Multi-modality imaging to determine the role of calcification and inflammation on restenosis rates following lower limb angioplasty: The CIRLA Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN34690731

Enrollment

Registered

2017-08-15

Start date

2015-11-01

Completion date

Unknown

Last updated

2020-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease Circulatory System Peripheral Arterial Disease

Interventions

Patients are identified from vascular clinic or vascular inpatient wards. As part of their usual clinical stream, participants are assessed and, if it is deemed appropriate, are scheduled to have a SF

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

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

Countries

United Kingdom

Contacts

Public ContactMohammed Chowdhury

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026