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Contribution of Optical Coherence Tomography in the Endovascular Treatment of Femoral Occlusions (TOCAF)

Primary Purpose

Superficial Femoral Artery Stenosis, Claudication, Ischemic Leg

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
femoropopliteal revascularization for TASC C or TASC D lesion
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Superficial Femoral Artery Stenosis focused on measuring femoral recanalization, optical coherence tomography (OCT), endovascular treatment, TASC-C,, TASC-D

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Insitut Coeur-Poumon, CHURecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

angiography 2D

angiography 2D with OCT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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%.

Secondary Outcome Measures

Primary patency rate at 1 year.
Target lesion revascularisation
corresponds to the occurrence of a re-intervention on the treated segment to maintain or restore permeability
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.
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.

Full Information

First Posted
June 8, 2020
Last Updated
May 23, 2022
Sponsor
University Hospital, Lille
Collaborators
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT04434586
Brief Title
Contribution of Optical Coherence Tomography in the Endovascular Treatment of Femoral Occlusions
Acronym
TOCAF
Official Title
Contribution of Optical Coherence Tomography in the Endovascular Treatment of Femoral Occlusions
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2020 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Abbott

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Superficial Femoral Artery Stenosis, Claudication, Ischemic Leg
Keywords
femoral recanalization, optical coherence tomography (OCT), endovascular treatment, TASC-C,, TASC-D

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
166 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
angiography 2D
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
angiography 2D with OCT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
femoropopliteal revascularization for TASC C or TASC D lesion
Intervention Description
Femoropopliteal revascularization: ATL or ATL/stenting for TASC C/D lesions. Control group: only angiography 2D final control. Experimental group: angiography + OCT control
Primary Outcome Measure Information:
Title
Primary patency rate at 1 year.
Description
The permeability rate is defined by the echodoppler criteria: PVS>2.4m/s or appearance of stenosis on the previously treated segment >70%.
Time Frame
at 12 months (+/- 2months)
Secondary Outcome Measure Information:
Title
Primary patency rate at 1 year.
Time Frame
at 1month (+/- 10days), 6months (+/- 1month)
Title
Target lesion revascularisation
Description
corresponds to the occurrence of a re-intervention on the treated segment to maintain or restore permeability
Time Frame
at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
Title
Target vessel revascularisation
Description
corresponds to the occurrence of a re-intervention on the previously treated artery, whatever the level, in order to maintain its permeability.
Time Frame
at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
Title
cost-effectiveness analyses
Description
Cost-effectiveness analysis between 2 therapeutic strategies: The costs related to each strategy are calculated taking into account the direct and indirect costs.
Time Frame
at 12 months (+/- 2months)
Other Pre-specified Outcome Measures:
Title
Rutherford scale considered ordinal variable
Description
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).
Time Frame
at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
Title
Variation in Ankle Brachial Index between randomization and 1, 6, 12 months on the revascularized limb in the study.
Description
Ankle-brachial index defined as the ratio of the blood pressure at the ankle to the blood pressure in the upper arm
Time Frame
at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
Title
Variation in quality of life assessed by Walk Impairment Questionnary between randomization and 1, 6, 12 months.
Description
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
Time Frame
at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
Title
Variation in quality of life assessed by EQ5D scores between randomization and 1, 6, 12 months.
Description
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)
Time Frame
at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
Title
Limb Rescue Rate
Time Frame
at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan Sobocinski, MD,PhD
Phone
0320445911
Email
jonathan.sobocinski@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Sobocinski, MD,PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Insitut Coeur-Poumon, CHU
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
0320445962
First Name & Middle Initial & Last Name & Degree
Jonathan SOBOCINSKI, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
32634565
Citation
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.
Results Reference
derived

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

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