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)

NCT02580084 | Completed

• 1 other identifier: NRICP111
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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

Study Arms (2)

aorta femoral bypass

ACTIVE COMPARATOR

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

hybrid intervention

EXPERIMENTAL

Iliac Arteries With Stenting and Plasty of the Common Femoral Artery

Procedure: Hybrid Intervention

Interventions

Hybrid Intervention PROCEDURE

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.

hybrid intervention

Aorta femoral Bypass PROCEDURE

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.

aorta femoral bypass

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation: lead

Study Sites (1)

NRICP

Novosibirsk, 630055, Russia

Location

Related Publications (1)

• 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.

  PMID: 35283003 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2015
• First Posted: October 20, 2015
• Study Start: August 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: March 1, 2021
• Last Updated: October 11, 2021

Record last verified: 2021-05

Locations

RU (1)