Study of the AFB and Stenting of the Iliac Arteries

Aorta-iliac Segment Lesion (C,D Type by TASC II) Clinical Trial

Official title:

Prospective Randomized Clinical Study of the Aorto-femoral Bypass and the Iliac Arteries With Stenting Recanalization Effectiveness in Patients With the Iliac Segment Occlusive Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02209350
• Other study ID #: TASC C,D
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: August 2, 2014
• Est. completion date: December 2022

Study information

• Verified date: May 2020
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to compare effectiveness and long-term results of aorta-femoral reconstructions and endovascular treatment in the patients with aorta-iliac lesions (TASC C,D).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 202
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with occlusive lesions of C and D type iliac segment, 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 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

• Patients with significant common femoral artery lesion

• Patient refusal to participate or continue to participate in the study

Related Conditions & MeSH terms

• Aorta-iliac Segment Lesion (C,D Type by TASC II)

Intervention

Procedure:
• Aorta-femoral bypass
Access to the femoral artery is performed through a lateral incision from the inguinal ligament. Operations technique on the abdominal aorta. Aorta-femoral bypass. Proximal anastomosis between the prosthesis and aorta is applied in the sort of "end-to-side" in the reconstruction by shunting. After jaws prosthesis conduction on hip distal anastomosis is formed with twisting controlling. In a case of preserved antegrade blood flow the femoral artery anastomosis applied in the sort of "end-to-side". If antegrade flow is absent, anastomosis is formed in the sort of "end to end".
• Recanalization and stenting of aorta-iliac segment
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).

Drug:
• Therapy: aspirin and clopidogrel
prescribed long-term aspirin (100 mg daily) and clopidogrel for 3 months (75 mg daily).

Locations

Country	Name	City	State
Russian Federation	Novosibirsk Research Institute of Circulation Pathology	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	The primary composite endpoint (efficacy): primary patency, secondary patency	If a damage confirmed by duplex is detected, repeat intervention is performed on the side of the examined segment. The physiological parameter and questionnaire will be used.	30 days
Primary	success of the procedure	Technical ability to perform the surgical intervention	30 days
Primary	safeness: clinically significant bleeding, hematoma, infection of the prosthesis, infection of postoperative wound, lymphorrhea, renal failure, myocardial infarction, stroke, mortality, thrombosis of the operated segment, distal embolism	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
Secondary	mortality in the long-term postoperative period		3 years
Secondary	stroke in the remote postoperative period		3 years
Secondary	myocardial infarction in the remote postoperative period		3 years
Secondary	preservation of limb in the long-term postoperative period		3 years