Pilot Randomized Clinical Study of the Iliac Arteries and Common Femoral Artery With Stenting and the Iliac Arteries With Stenting and Plasty of the Common Femoral Artery (TASC CD)
Primary Purpose
Atherosclerosis of the Peripheral Arteries
Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Iliac segment recanalization and stenting Iliac segment Common Femoral Artery (CFA)
Iliac segment recanalization, stenting and plastic Common Femoral Artery (CFA) patch
Sponsored by

About this trial
This is an interventional treatment trial for Atherosclerosis of the Peripheral Arteries focused on measuring TASC C, D, CFA, Supera, iliac arteries, common femoral artery, plasty of the common femoral artery, stenting Supera
Eligibility Criteria
Inclusion Criteria:
- Patients with occlusive lesions of C and D type iliac segment and CFA lesion, and with chronic lower limb ischemia (II-IV degree by Fontaine, 4-6 degree by Rutherford), age: 47-75 years old.
- Patients who consented to participate in this study.
Exclusion Criteria:
- Chronic heart failure of III-IV functional class by New York Heart Association (NYHA) classification.
- Decompensated chronic "pulmonary" heart
- Severe hepatic or renal failure (bilirubin> 35 mmol / l, glomerular filtration rate <60 mL / min);
- Polyvalent drug allergy
- Cancer in the terminal stage with a life expectancy less than 6 months;
- Acute ischemic
- Expressed aortic calcification tolerant to angioplasty
- Patient refusal to participate or continue to participate in the study
Sites / Locations
- NRICPRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Iliac segment recanalization and stenting Iliac segment CFA
Iliac segment recanalization, stenting and plastic CFA patch
Arm Description
Iliac segment recanalization and stenting Iliac segment Common Femoral Artery (CFA)
Iliac segment recanalization, stenting and plastic Common Femoral Artery (CFA) patch
Outcomes
Primary Outcome Measures
Primary patency of the operated segment
during the whole period of observation. confirmation of patency of the arterial ultrasound of the operated segment. Confirmation patency of artery 24 months after surgery using Multislice computed tomography angiography of the lower extremities
Secondary Outcome Measures
Secondary patency of the operated artery restenosis
during the whole period of observation. confirmation of patency of the arterial ultrasound of the operated segment. Confirmation patency of artery 24 months after surgery using Multislice computed tomography angiography of the lower extremities
reocclusion
during the whole period of observation. confirmation of patency of the arterial ultrasound of the operated segment. Confirmation patency of artery 24 months after surgery using Multislice computed tomography angiography of the lower extremities
postoperative bleeding
assessment of bleeding within 30 days after surgery. The identification of bleeding with physical examination and ultrasound.Considered bleeding requiring surgical intervention
hematoma
myocardial infarction
mortality
limb amputation
infection
Full Information
NCT ID
NCT03315884
First Posted
October 17, 2017
Last Updated
May 26, 2020
Sponsor
Meshalkin Research Institute of Pathology of Circulation
Collaborators
Abbott
1. Study Identification
Unique Protocol Identification Number
NCT03315884
Brief Title
Pilot Randomized Clinical Study of the Iliac Arteries and Common Femoral Artery With Stenting and the Iliac Arteries With Stenting and Plasty of the Common Femoral Artery
Acronym
TASC CD
Official Title
Pilot Randomized Clinical Study of the Iliac Arteries and Common Femoral Artery With Stenting Supera and the Iliac Arteries With Stenting and Plasty of the Common Femoral Artery Effectiveness in Patients With the Iliac and CFA Segment Occlusive or Stenosis Disease (TASC C, D)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation
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
According to the recommendations of the Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) statement and the Russian guidelines for limb ischemia treatment (2010), reconstructive surgery is preferred for type D lesions.
Detailed Description
According to the recommendations of the Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) statement and the Russian guidelines for limb ischemia treatment (2010), reconstructive surgery is preferred for type D lesions. Patients with type C lesions can be managed by either stenting or bypass surgery. Despite the fact that aorta-femoral reconstructions long-term results are better than the diffuse aorta-iliac lesions endovascular treatment results, the surgery risk is significantly higher than the endovascular surgery risk regarding criteria of mortality, complications, and return to normal activity.
All reports of iliac arteries stenosis percutaneous angioplasty indicate that the primary technical and clinical success rate exceeds 90%. The figure reaches 100% in the case of local lesions. The technical success of iliac arteries long occlusions recanalization reaches 80-85%. Improvement of endovascular equipment designed for the total occlusions treatment increases technical success of recanalization. The TASC II materials summarize the several large studies results which present the data on the operated segment artery patency at the level of 70-81% within 5-8 years of follow up. A large number of authors note the actuality of aortic-iliac type C and D segment lesions endovascular treatment recommendations revision according to the TASC II.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis of the Peripheral Arteries
Keywords
TASC C, D, CFA, Supera, iliac arteries, common femoral artery, plasty of the common femoral artery, stenting Supera
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Iliac segment recanalization and stenting Iliac segment CFA
Arm Type
Experimental
Arm Description
Iliac segment recanalization and stenting Iliac segment Common Femoral Artery (CFA)
Arm Title
Iliac segment recanalization, stenting and plastic CFA patch
Arm Type
Active Comparator
Arm Description
Iliac segment recanalization, stenting and plastic Common Femoral Artery (CFA) patch
Intervention Type
Procedure
Intervention Name(s)
Iliac segment recanalization and stenting Iliac segment Common Femoral Artery (CFA)
Other Intervention Name(s)
Endovascular intervention
Intervention Description
Retrograde femoral access. Brachial access. Standard endovascular access is performed under local anesthesia and affected arterial segment is visualized. Stenosis or artery occlusion is passed with hydrophilic guide. In case of occlusion transluminal or subintimal (often "mixed") artery recanalization is performed. To maximize the preservation of the affected artery initial patency, occlusion recanalization is performed by ante-and retrograde accesses. Then stenosis or occlusion predilation is performed with balloon catheter (balloon catheter diameter is smaller than the affected artery diameter for 1-2 mm). After control angiography stent is installed in the aorta-iliac area throughout the lesion (lesion diameter corresponds to the stenotic arteries diameter). In aorta-iliac zone balloon-expandable and self-expandable stents are used.
Intervention Type
Procedure
Intervention Name(s)
Iliac segment recanalization, stenting and plastic Common Femoral Artery (CFA) patch
Other Intervention Name(s)
Hybrid Intervention
Intervention Description
Standard access to the CFA is performed. Outflow ways and CFA capability for reconstruction are determined. The puncture of the general CFA (retrograde) is performed and the introducer 7Fr. is set. Recanalization of iliac artery occlusion. It is necessary to cross the iliac occlusion in a retrograde fashion first and secure aortic inflow before making the arteriotomy. An ipsilateral, a contralateral and a brachial approaches are used depending on the clinical situation. If the retrograde access to the aorta failed, you use the antegrade crossing of the iliac occlusion with no intention to reenter the lumen in the CFA. After the recanalization and balloon angioplasty of iliac artery we completed the procedure with endarterectomy of CFA, patch closure and iliac stenting. The preference is to perform endarterectomy and patch before iliac stenting because it can be difficult to access the true lumen in a difficult CFA lesion. Controlling angiography were performed. Closing approach.
Primary Outcome Measure Information:
Title
Primary patency of the operated segment
Description
during the whole period of observation. confirmation of patency of the arterial ultrasound of the operated segment. Confirmation patency of artery 24 months after surgery using Multislice computed tomography angiography of the lower extremities
Time Frame
during the whole period of observation. Observation is 24 month after surgery
Secondary Outcome Measure Information:
Title
Secondary patency of the operated artery restenosis
Description
during the whole period of observation. confirmation of patency of the arterial ultrasound of the operated segment. Confirmation patency of artery 24 months after surgery using Multislice computed tomography angiography of the lower extremities
Time Frame
during the whole period of observation. Observation is 24 month after surgery
Title
reocclusion
Description
during the whole period of observation. confirmation of patency of the arterial ultrasound of the operated segment. Confirmation patency of artery 24 months after surgery using Multislice computed tomography angiography of the lower extremities
Time Frame
during the whole period of observation. Observation is 24 month after surgery
Title
postoperative bleeding
Description
assessment of bleeding within 30 days after surgery. The identification of bleeding with physical examination and ultrasound.Considered bleeding requiring surgical intervention
Time Frame
in the early postoperative period. Surveillance is 30 days after surgery
Title
hematoma
Time Frame
in the early postoperative period. Surveillance is 30 days after surgery
Title
myocardial infarction
Time Frame
during the whole period of observation. Observation is 24 month after surgery
Title
mortality
Time Frame
during the whole period of observation. Observation is 24 month after surgery
Title
limb amputation
Time Frame
during the whole period of observation. Observation is 24 month after surgery
Title
infection
Time Frame
during the whole period of observation. Observation is 24 month after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
47 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with occlusive lesions of C and D type iliac segment and CFA lesion, and with chronic lower limb ischemia (II-IV degree by Fontaine, 4-6 degree by Rutherford), age: 47-75 years old.
Patients who consented to participate in this study.
Exclusion Criteria:
Chronic heart failure of III-IV functional class by New York Heart Association (NYHA) classification.
Decompensated chronic "pulmonary" heart
Severe hepatic or renal failure (bilirubin> 35 mmol / l, glomerular filtration rate <60 mL / min);
Polyvalent drug allergy
Cancer in the terminal stage with a life expectancy less than 6 months;
Acute ischemic
Expressed aortic calcification tolerant to angioplasty
Patient refusal to participate or continue to participate in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vyacheslav Mitrofanov
Phone
+79139255543
Email
v_mitrofanov@meshalkin.ru
Facility Information:
Facility Name
NRICP
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Pilot Randomized Clinical Study of the Iliac Arteries and Common Femoral Artery With Stenting and the Iliac Arteries With Stenting and Plasty of the Common Femoral Artery
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