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

NCT04434586 | Recruiting

• 2 other identifiers: 2018_882019-A01055-52
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Superficial Femoral Artery Stenosis; Claudication; Ischemic Leg

Keywords

femoral recanalization; optical coherence tomography (OCT); endovascular treatment; TASC-C,; TASC-D

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Primary patency rate at 1 year.

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

• Target lesion revascularisation

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

• Target vessel revascularisation

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

• cost-effectiveness analyses

  at 12 months (+/- 2months)

Other Outcomes (5)

• Rutherford scale considered ordinal variable

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

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

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

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

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

Study Arms (2)

angiography 2D

SHAM COMPARATOR

Control group: an arteriography will be performed on the entire treated segment to assess the quality of the result, the application or not an active balloon will be left to the discretion of the operator. In case of application of the active balloon, a new arteriography before decision or not the use of stenting will be practiced. In case of stenting, an arteriographic final is performed.

Device: femoropopliteal revascularization for TASC C or TASC D lesion

angiography 2D with OCT

EXPERIMENTAL

Experimental group: an arteriography and OCT acquisition on the entire treated segment to ensure the quality of the result, the application or not of an active ball will be left. In case of application of the active balloon, a new arteriography and OCT acquisition before decision or not the use of stenting will be practiced. In case of stenting, a final arteriography and then OCT acquisition are performed.

Device: femoropopliteal revascularization for TASC C or TASC D lesion

Interventions

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

angiography 2D; angiography 2D with OCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Abbott: collaborator
• University Hospital, Lille: lead

Study Sites (1)

Insitut Coeur-Poumon, CHU

Lille, 59037, France

RECRUITING

Related Publications (1)

• Dubosq M, Goueffic Y, Duhamel A, Denies F, Dervaux B, Goyault G, Sobocinski J. Optical Coherence Tomography Contribution Assessment in the Revascularization of Long Femoropopliteal Occlusive Lesions (TASC C and D): A Randomized Trial. Ann Vasc Surg. 2021 Jan;70:362-369. doi: 10.1016/j.avsg.2020.06.061. Epub 2020 Jul 4.

  PMID: 32634565 RESULT

MeSH Terms

Conditions

Intermittent Claudication

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jonathan Sobocinski, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Sobocinski, MD,PhD

CONTACT

0320445911; jonathan.sobocinski@chru-lille.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 17, 2020
• Study Start: June 16, 2020
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

FR (1)