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NCT Number: NCT04434586

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

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.

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Key information

Conditions

Superficial Femoral Artery Stenosis Cardiovascular Diseases Claudication Intermittent Claudication Ischemic Leg Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Insitut Coeur-Poumon, CHU

Lille, 59037, France

Location status: Recruiting

Location contact

Jonathan SOBOCINSKI, MD

PRINCIPAL_INVESTIGATOR

CONTACT

0320445962

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

femoropopliteal revascularization for TASC C or TASC D lesion

Device

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

Primary outcomes

  1. Primary patency rate at 1 year.

    Time frame: at 12 months (+/- 2months)

    The permeability rate is defined by the echodoppler criteria: PVS>2.4m/s or appearance of stenosis on the previously treated segment >70%.

Secondary outcomes

  1. Primary patency rate at 1 year.

    Time frame: at 1month (+/- 10days), 6months (+/- 1month)

  2. Target lesion revascularisation

    Time frame: at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)

    corresponds to the occurrence of a re-intervention on the treated segment to maintain or restore permeability

  3. Target vessel revascularisation

    Time frame: at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)

    corresponds to the occurrence of a re-intervention on the previously treated artery, whatever the level, in order to maintain its permeability.

  4. cost-effectiveness analyses

    Time frame: at 12 months (+/- 2months)

    Cost-effectiveness analysis between 2 therapeutic strategies: The costs related to each strategy are calculated taking into account the direct and indirect costs.

Other outcomes

  1. Rutherford scale considered ordinal variable

    Time frame: at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)

    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).

  2. Variation in Ankle Brachial Index between randomization and 1, 6, 12 months on the revascularized limb in the study.

    Time frame: at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)

    Ankle-brachial index defined as the ratio of the blood pressure at the ankle to the blood pressure in the upper arm

  3. Variation in quality of life assessed by Walk Impairment Questionnary between randomization and 1, 6, 12 months.

    Time frame: at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)

    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

  4. Variation in quality of life assessed by EQ5D scores between randomization and 1, 6, 12 months.

    Time frame: at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)

    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)

  5. Limb Rescue Rate

    Time frame: at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)

Study contacts

Contact information is provided by the study sponsor or research team.

Jonathan Sobocinski, MD,PhD

CONTACT

[email protected]

0320445911

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Abbott

Registry information

Acronym: TOCAF

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jun 17, 2020
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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