Retrograde Recanalization of Infrainguinal Arterial Occlusive Disease.
Primary Purpose
Critical Limb Ischemia
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
retrograde access for re-canalization of infra-inguinal arterial occlusive disease
Sponsored by
About this trial
This is an interventional treatment trial for Critical Limb Ischemia
Eligibility Criteria
Inclusion Criteria:
patients with;
- CLI consistent with Rutherford categories (4-5).
- Infrainguinal arterial occlusive disease with a patent distal part of at least one tibial vessel runoff to the foot.
Exclusion Criteria:
patients with the following conditions will be excluded:
- Non-salvageable limbs.
- Life threatening infections requiring major amputation.
- Ulcers at the area of intended puncture.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
patients with infrainguinal arterial occlusive disease after failed antegrade approach
Arm Description
Outcomes
Primary Outcome Measures
safety of retrograde approach as regard occurrence of procedure specific complications
safety of retrograde approach after failed antegrade approach for recanalization of infrainguinal arterial occlusive disease, in the light of complications which are classified into major or minor according to the reporting standards of society of vascular surgery.this complications will be looked for and data will be collected
feasibility of retrograde approach as regard successful retrograde puncture and technical success after failed antegrade approach for recanalization of infrainguinal arterial occlusive disease.
it means that this approach can be used successfuly in clinical practice and this will be assessd by measuring successful retrograde puncture and technical success.
successful retrograde puncture means successful performance of retrograde puncture at any of the retrograde distal puncture sites with intraluminal placement of the retrograde guidewire confirmed by contrast angiography without causing procedure specific complications namely local dissection, rupture, or an arteriovenous fistula at puncture site.
technical success is defined as successful puncture followed by successful crossing of the occlusion and regain of inline flow to the foot with less than 30%residual stenosis after treatment.
Secondary Outcome Measures
clinical success of the procedure
immediate clinical success is defined as regain of distal pulses, revascularization warmness and edema, and/or disappearance of rest pain.
One year limb salvage rate of the procedure
limb salvage is defined as healing of existing wounds with no amputation proximal to metatarsus.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04974905
Brief Title
Retrograde Recanalization of Infrainguinal Arterial Occlusive Disease.
Official Title
Retrograde Approach for Management of Infrainguinal Arterial Occlusive Disease After Failed Antegrade Approach in Critical Limb Ischemia Patients; Feasibility, Safety, and Procedure Related Outcomes.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2021 (Anticipated)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
August 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
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
The spectrum of lower extremity peripheral arterial disease (PAD) ranges from exhibiting no symptoms to limb threatening gangrene. The number of patients living with it is rising steadily owing to increased life expectancy, obesity, diabetes, and tobacco consumption.
Critical limb ischemia (CLI) is the terminal and the most serious stage of PAD in which blood flow to the lower extremity does not meet metabolic demands of the tissues at rest. The diagnosis is mainly clinical and patients are presented with rest pain, minimal tissue loss or frank gangrene.
Revascularization strategies include endovascular procedures and surgical bypass.Endovascular therapy has evolved as an attractive, minimally invasive method of revascularization especially in the more frequently encountered patients with medical and anatomical contraindications to surgical revascularization.
Antegrade approach is the standard approach in infrainguinal arterial occlusive disease,however, failure occurs in about 20% of infrainguinal attempts.Retrograde approach is used as a backup technique in failed cases.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Limb Ischemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patients with infrainguinal arterial occlusive disease after failed antegrade approach
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
retrograde access for re-canalization of infra-inguinal arterial occlusive disease
Intervention Description
after failed antegrade approach for re-canalization of infra-inguinal arterial occlusive disease( failed reentry into the distal true lumen), the retrograde approach will be attempted
Primary Outcome Measure Information:
Title
safety of retrograde approach as regard occurrence of procedure specific complications
Description
safety of retrograde approach after failed antegrade approach for recanalization of infrainguinal arterial occlusive disease, in the light of complications which are classified into major or minor according to the reporting standards of society of vascular surgery.this complications will be looked for and data will be collected
Time Frame
within one year of follow up
Title
feasibility of retrograde approach as regard successful retrograde puncture and technical success after failed antegrade approach for recanalization of infrainguinal arterial occlusive disease.
Description
it means that this approach can be used successfuly in clinical practice and this will be assessd by measuring successful retrograde puncture and technical success.
successful retrograde puncture means successful performance of retrograde puncture at any of the retrograde distal puncture sites with intraluminal placement of the retrograde guidewire confirmed by contrast angiography without causing procedure specific complications namely local dissection, rupture, or an arteriovenous fistula at puncture site.
technical success is defined as successful puncture followed by successful crossing of the occlusion and regain of inline flow to the foot with less than 30%residual stenosis after treatment.
Time Frame
within one year of follow up
Secondary Outcome Measure Information:
Title
clinical success of the procedure
Description
immediate clinical success is defined as regain of distal pulses, revascularization warmness and edema, and/or disappearance of rest pain.
Time Frame
within one year of follow up
Title
One year limb salvage rate of the procedure
Description
limb salvage is defined as healing of existing wounds with no amputation proximal to metatarsus.
Time Frame
within one year of follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with;
CLI consistent with Rutherford categories (4-5).
Infrainguinal arterial occlusive disease with a patent distal part of at least one tibial vessel runoff to the foot.
Exclusion Criteria:
patients with the following conditions will be excluded:
Non-salvageable limbs.
Life threatening infections requiring major amputation.
Ulcers at the area of intended puncture.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mostafa A Foda, Msc
Phone
01012514518
Email
m_foda_revolution2020@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hussein K Hussein, Professor
Phone
01222142667
12. IPD Sharing Statement
Citations:
PubMed Identifier
31834669
Citation
Mustapha JA, Saab F, McGoff TN, Adams G, Mullins JR, Al-Dadah A, Jaff MR, Goodney PP, Khawaja F, Diaz-Sandoval LJ. Tibiopedal arterial minimally invasive retrograde revascularization (TAMI) in patients with peripheral arterial disease and critical limb ischemia. On behalf of the Peripheral Registry of Endovascular Clinical Outcomes (PRIME). Catheter Cardiovasc Interv. 2020 Feb 15;95(3):447-454. doi: 10.1002/ccd.28639. Epub 2019 Dec 13.
Results Reference
background
PubMed Identifier
25241321
Citation
Hendricks NJ, Sabri SS. Subintimal arterial flossing with antegrade-retrograde intervention (SAFARI) and rertograde access for critical limb ischemia. Tech Vasc Interv Radiol. 2014 Sep;17(3):203-10. doi: 10.1053/j.tvir.2014.08.009. Epub 2014 Sep 4.
Results Reference
background
PubMed Identifier
24650744
Citation
Bazan HA, Le L, Donovan M, Sidhom T, Smith TA, Sternbergh WC 3rd. Retrograde pedal access for patients with critical limb ischemia. J Vasc Surg. 2014 Aug;60(2):375-81. doi: 10.1016/j.jvs.2014.02.038. Epub 2014 Mar 18.
Results Reference
background
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Retrograde Recanalization of Infrainguinal Arterial Occlusive Disease.
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