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)

Atherosclerosis of the Peripheral Arteries Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02580084
• Other study ID #: NRICP111
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: March 2021

Study information

• Verified date: May 2021
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: March 2021
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerosis of the Peripheral Arteries

Intervention

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.
• 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.

Locations

Country	Name	City	State
Russian Federation	NRICP	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Evaluation of efficiency: success of procedures	Technical feasibility of the procedure	30 days
Secondary	mortality		during the whole period of observation. Observation is 36 month after surgery
Secondary	stroke		during the whole period of observation. Observation is 36 month after surgery
Secondary	myocardial infarction		during the whole period of observation. Observation is 36 month after surgery
Secondary	limb salvage		in the early postoperative period. Surveillance is 36 month after surgery
Secondary	infection of the prosthesis		during the whole period of observation. Observation is 36 month after surgery