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)

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)

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.

Study Overview

• Status: Completed
• Conditions: Atherosclerosis of the Peripheral Arteries
• Intervention / Treatment: Procedure: Aorta femoral Bypass; Procedure: Hybrid Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 202
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Novosibirsk, Russian Federation, 630055
    • NRICP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: aorta femoral bypass; 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.	Procedure: Aorta femoral Bypass; 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.
Experimental: hybrid intervention; Iliac Arteries With Stenting and Plasty of the Common Femoral Artery	Procedure: Hybrid Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	30 days
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	30 days
Evaluation of efficiency: success of procedures	Technical feasibility of the procedure	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
mortality	during the whole period of observation. Observation is 36 month after surgery
stroke	during the whole period of observation. Observation is 36 month after surgery
myocardial infarction	during the whole period of observation. Observation is 36 month after surgery
limb salvage	in the early postoperative period. Surveillance is 36 month after surgery
infection of the prosthesis	during the whole period of observation. Observation is 36 month after surgery

Collaborators and Investigators

• Sponsor: Meshalkin Research Institute of Pathology of Circulation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: October 14, 2015
• First Submitted That Met QC Criteria: October 17, 2015
• First Posted (Estimate): October 20, 2015

Study Record Updates

• Last Update Posted (Actual): October 11, 2021
• Last Update Submitted That Met QC Criteria: October 4, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• 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
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis
• Other Study ID Numbers: NRICP111