Contribution of Optical Coherence Tomography in the Endovascular Treatment of Femoral Occlusions

Claudication Clinical Trial

— TOCAF  

Official title:

Contribution of Optical Coherence Tomography in the Endovascular Treatment of Femoral Occlusions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04434586
• Other study ID #: 2018_88
• Secondary ID: 2019-A01055-52
• Status: Recruiting
• Phase: N/A
• Start date: June 16, 2020
• Est. completion date: July 2024

Study information

• Verified date: May 2022
• Source: University Hospital, Lille
• Contact: Jonathan Sobocinski, MD,PhD
• Phone: 0320445911
• Email: jonathan.sobocinski[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a common care study. A study for evaluating the quality of balloon inflation and stent application will be performed in 2D angiography alone in the control group and then by 2D and OCT angiography for the experimental group. The benefit could be an improvement in the results of revascularization of femoropopliteal lesions thanks to OCT which allows a 3D visualization of the arterial lumen.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 166
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient over 18 years old

• Femoral-popliteal lesion TASC-C or TASC-D de novo (F1 to P1)

• Starting lesion on the superficial femoral artery and not extending beyond the intercondylar notch (P2)

• =1 continuous permeable leg axis directly injecting the plantar arch

• Rutherford 2-5

Exclusion Criteria:

• Patient under personal protection regime (tutorship, guardianship)

• Absence of arterial axis in permeable leg

• Patient presenting a limb acute ischaemia (chart evolving since less than 14 days)

• Patient without favorable element to consider healing

• History of stents on the femoropopliteal axis

• History of femoropopliteal bypass

• Untreated stenosis =30% on the iliac axis and common femoral upstream

• Popliteal lesion beyond the intercondylar notch (P2)

Related Conditions & MeSH terms

• Claudication
• Intermittent Claudication
• Ischemic Leg
• Superficial Femoral Artery Stenosis

Intervention

Device:
• femoropopliteal revascularization for TASC C or TASC D lesion
Femoropopliteal revascularization: ATL or ATL/stenting for TASC C/D lesions. Control group: only angiography 2D final control. Experimental group: angiography + OCT control

Locations

Country	Name	City	State
France	Insitut Coeur-Poumon, CHU	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Abbott

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rutherford scale considered ordinal variable	Rutherford grade of 2-4 for their target leg. The Rutherford scale is an indicator for the severity of Peripheral Vascular Disease: 0 = no symptoms, 6 = functional foot is no longer salvageable (leading to foot amputation).	at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
Other	Variation in Ankle Brachial Index between randomization and 1, 6, 12 months on the revascularized limb in the study.	Ankle-brachial index defined as the ratio of the blood pressure at the ankle to the blood pressure in the upper arm	at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
Other	Variation in quality of life assessed by Walk Impairment Questionnary between randomization and 1, 6, 12 months.	a questionnaire for evaluating walking impairment in patients; Parameters: difficulty walking a distance during the past month; difficulty walking at a certain speed during the past month; symptoms associated with walking impairment	at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
Other	Variation in quality of life assessed by EQ5D scores between randomization and 1, 6, 12 months.	overall score on a numeric scale "check the box that best describes your health today", 5 themes (mobility, autonomy of the person, common activities, pain / discomfort, anxiety / depression)	at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
Other	Limb Rescue Rate		at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
Primary	Primary patency rate at 1 year.	The permeability rate is defined by the echodoppler criteria: PVS>2.4m/s or appearance of stenosis on the previously treated segment >70%.	at 12 months (+/- 2months)
Secondary	Primary patency rate at 1 year.		at 1month (+/- 10days), 6months (+/- 1month)
Secondary	Target lesion revascularisation	corresponds to the occurrence of a re-intervention on the treated segment to maintain or restore permeability	at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
Secondary	Target vessel revascularisation	corresponds to the occurrence of a re-intervention on the previously treated artery, whatever the level, in order to maintain its permeability.	at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
Secondary	cost-effectiveness analyses	Cost-effectiveness analysis between 2 therapeutic strategies: The costs related to each strategy are calculated taking into account the direct and indirect costs.	at 12 months (+/- 2months)