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Clinical Study of the Aorta-femoral Bypass and Hybrid Intervention and the Iliac Arteries With Stenting and Plasty of the Common Femoral Artery Effectiveness in Patients With the Iliac Segment and Femoral Artery Occlusive Disease (TASC C, D)

Primary Purpose

Atherosclerosis of the Peripheral Arteries

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Hybrid Intervention
Aorta femoral Bypass
Sponsored by
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atherosclerosis of the Peripheral Arteries focused on measuring atherosclerosis of the peripheral arteries, Aorta-femoral Bypass, Hybrid Intervention, Iliac Arteries With Stenting and Plasty of the Common Femoral Artery, plastic arteries with lesions of the common femoral artery and deep femoral artery

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with occlusive lesions of C and D type iliac segment and steno-occlusive lesions of the common femoral artery, and with chronic lower limb ischemia (II-IV degree by Fontaine, 2-5 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 classification.
  • Patients who have suffered a stroke or myocardial infarction less than 3 months
  • Significant Steno-occlusive lesion of the contralateral side
  • Decompensated chronic "pulmonary" heart
  • Aortoarteritis
  • 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
  • Expressed aortic calcification tolerant to angioplasty
  • Patient refusal to participate or continue to participate in the study

Sites / Locations

  • NRICP

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

aorta femoral bypass

hybrid intervention

Arm Description

It is sufficient to identify only the anterior-lateral aorta surface. After heparinization the aorta is clamped above and below the anastomosis. The aorta is dissected along the anterior wall, calcium portions or mural thrombus are removed. Prosthesis is cut obliquely and anastomosis suturing starts with distal angle. Occluded at the prosthetic base jaws, aortic compressor is removed, restoring blood flow in the lower limb. Next stage is tunnel creating for jaws prosthesis conduction on hip. Ureters must remain over the prosthesis, jaw should be above the iliac arteries. After jaws prosthesis conduction on hip distal anastomosis is formed with twisting controlling. Before anastomosis completion the testing jaws and all arteries bloodletting is performed.

Iliac Arteries With Stenting and Plasty of the Common Femoral Artery

Outcomes

Primary Outcome Measures

Safety assessment in the 30-day period: clinically significant bleeding, hematoma, infection of the prosthesis, infection of the postoperative wound, lymphorrhea, renal failure, myocardial infarction, stroke, mortality, thrombosis of the operated segment
Identification of serious adverse events requiring correction of therapy or surgery. Will be used physiological parameter and questionnaire. Classification of bleeding will be used GUSTO (Severe or moderate)
Evaluation of efficiency: primary patency, secondary patency success of procedures, length of hospital stay
If a damage confirmed by duplex is detected, repeat intervention is performed on the side of the examined segment
Evaluation of efficiency: success of procedures
Technical feasibility of the procedure

Secondary Outcome Measures

mortality
stroke
myocardial infarction
limb salvage
infection of the prosthesis

Full Information

First Posted
October 14, 2015
Last Updated
October 4, 2021
Sponsor
Meshalkin Research Institute of Pathology of Circulation
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1. Study Identification

Unique Protocol Identification Number
NCT02580084
Brief Title
Clinical Study of the Aorta-femoral Bypass and Hybrid Intervention and the Iliac Arteries With Stenting and Plasty of the Common Femoral Artery Effectiveness in Patients With the Iliac Segment and Femoral Artery Occlusive Disease (TASC C, D)
Official Title
Prospective Randomized Clinical Study of the Aorta-femoral Bypass and Hybrid Intervention and the Iliac Arteries With Stenting and Plasty of the Common Femoral Artery Effectiveness in Patients With the Iliac Segment and Femoral Artery Occlusive Disease (TASC C, D)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
March 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Currently, according to the TASC II consensus document (2007) and the Russian guidelines for limb ischemia treatment (2010), aorta-iliac C and D type segment lesions the open surgery is suggested.
Detailed Description
Currently, according to the TASC II consensus document (2007) and the Russian guidelines for limb ischemia treatment (2010), aorta-iliac C and D type segment lesions the open surgery is suggested. According to different studies, 76% occlusive aorta-iliac article course patients indicate femoral-popliteal segment lesions. Due to the lack of inflow and outflow ways of correction needed for adequate limb revascularization surgery treatment of multistorey atherosclerotic lesions patients is still one of the most complex problems of vascular surgery. Perioperational mortality of critical limb ischemia patients reaches 5-10% in retrograde aorta-iliac segment reconstruction. Due to its high efficiency hybrid operative invasion is one of the most perspective directions in reconstructive vascular surgery development (92-98% of the cases with the small number of post-operative complications). Furthermore, hybrid surgery is possible with the critical iliac segment and femoral artery lesions, since stenting in the field of physiological bends (femoral artery) may lead to its breaking and artery thrombosis. Arterial segments blood flow reconstruction is possible with hybrid innervations meaning iliac segment stenting and common femoral artery patch. All reports of iliac arteries stenosis percutaneous angioplasty indicate that the primary technical and clinical success rate exceeds 90%. 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, together with hybrid technics implementation in this category of patients.

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
atherosclerosis of the peripheral arteries, Aorta-femoral Bypass, Hybrid Intervention, Iliac Arteries With Stenting and Plasty of the Common Femoral Artery, plastic arteries with lesions of the common femoral artery and deep femoral artery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aorta femoral bypass
Arm Type
Active Comparator
Arm Description
It is sufficient to identify only the anterior-lateral aorta surface. After heparinization the aorta is clamped above and below the anastomosis. The aorta is dissected along the anterior wall, calcium portions or mural thrombus are removed. Prosthesis is cut obliquely and anastomosis suturing starts with distal angle. Occluded at the prosthetic base jaws, aortic compressor is removed, restoring blood flow in the lower limb. Next stage is tunnel creating for jaws prosthesis conduction on hip. Ureters must remain over the prosthesis, jaw should be above the iliac arteries. After jaws prosthesis conduction on hip distal anastomosis is formed with twisting controlling. Before anastomosis completion the testing jaws and all arteries bloodletting is performed.
Arm Title
hybrid intervention
Arm Type
Experimental
Arm Description
Iliac Arteries With Stenting and Plasty of the Common Femoral Artery
Intervention Type
Procedure
Intervention Name(s)
Hybrid Intervention
Intervention Description
The puncture of the femoral artery general is executed and the introducer 7Fr is set. Further, the hydrophilic conductor executes a recanalization of the Vasa of iliac artery occlusion. if you cannot pass the occlusion retrograde is additional access to antegrade recanalization. Then using hydrophilic conductors, an iliac artery antegrade or retrograde recanalization of the Vasa is made. Femoral artery arteriotomy. Further execute a direct endarterectomy femoral artery and from the mouth of a hip artery. arteriotomy of the femoral artery is closed with a vascular patch use (synthetic or biological). Balloon angioplasty and stenting, iliac artery is done, the controlling angiography Closing maims.
Intervention Type
Procedure
Intervention Name(s)
Aorta femoral Bypass
Intervention Description
It is sufficient to identify only the anterior-lateral aorta surface. After heparinization the aorta is clamped above and below the anastomosis. The aorta is dissected along the anterior wall, calcium portions or mural thrombus are removed. Prosthesis is cut obliquely and anastomosis suturing starts with distal angle. Occluded at the prosthetic base jaws, aortic compressor is removed, restoring blood flow in the lower limb. Next stage is tunnel creating for jaws prosthesis conduction on hip. Ureters must remain over the prosthesis, jaw should be above the iliac arteries. After jaws prosthesis conduction on hip distal anastomosis is formed with twisting controlling. Before anastomosis completion the testing jaws and all arteries bloodletting is performed.
Primary Outcome Measure Information:
Title
Safety assessment in the 30-day period: clinically significant bleeding, hematoma, infection of the prosthesis, infection of the postoperative wound, lymphorrhea, renal failure, myocardial infarction, stroke, mortality, thrombosis of the operated segment
Description
Identification of serious adverse events requiring correction of therapy or surgery. Will be used physiological parameter and questionnaire. Classification of bleeding will be used GUSTO (Severe or moderate)
Time Frame
30 days
Title
Evaluation of efficiency: primary patency, secondary patency success of procedures, length of hospital stay
Description
If a damage confirmed by duplex is detected, repeat intervention is performed on the side of the examined segment
Time Frame
30 days
Title
Evaluation of efficiency: success of procedures
Description
Technical feasibility of the procedure
Time Frame
30 days
Secondary Outcome Measure Information:
Title
mortality
Time Frame
during the whole period of observation. Observation is 36 month after surgery
Title
stroke
Time Frame
during the whole period of observation. Observation is 36 month after surgery
Title
myocardial infarction
Time Frame
during the whole period of observation. Observation is 36 month after surgery
Title
limb salvage
Time Frame
in the early postoperative period. Surveillance is 36 month after surgery
Title
infection of the prosthesis
Time Frame
during the whole period of observation. Observation is 36 month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with occlusive lesions of C and D type iliac segment and steno-occlusive lesions of the common femoral artery, and with chronic lower limb ischemia (II-IV degree by Fontaine, 2-5 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 classification. Patients who have suffered a stroke or myocardial infarction less than 3 months Significant Steno-occlusive lesion of the contralateral side Decompensated chronic "pulmonary" heart Aortoarteritis 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 Expressed aortic calcification tolerant to angioplasty Patient refusal to participate or continue to participate in the study
Facility Information:
Facility Name
NRICP
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation

12. IPD Sharing Statement

Citations:
PubMed Identifier
35283003
Citation
Starodubtsev V, Mitrofanov V, Ignatenko P, Gostev A, Preece R, Rabtsun A, Saaya S, Popova I, Karpenko A. Editor's Choice - Hybrid vs. Open Surgical Reconstruction for Iliofemoral Occlusive Disease: A Prospective Randomised Trial. Eur J Vasc Endovasc Surg. 2022 Apr;63(4):557-565. doi: 10.1016/j.ejvs.2022.02.002. Epub 2022 Feb 9.
Results Reference
derived

Learn more about this trial

Clinical Study of the Aorta-femoral Bypass and Hybrid Intervention and the Iliac Arteries With Stenting and Plasty of the Common Femoral Artery Effectiveness in Patients With the Iliac Segment and Femoral Artery Occlusive Disease (TASC C, D)

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