Status:
UNKNOWN
Pilot Randomized Clinical Study of the Iliac Arteries and Common Femoral Artery With Stenting and the Iliac Arteries With Stenting and Plasty of the Common Femoral Artery
Lead Sponsor:
Meshalkin Research Institute of Pathology of Circulation
Collaborating Sponsors:
Abbott
Conditions:
Atherosclerosis of the Peripheral Arteries
Eligibility:
All Genders
47-75 years
Phase:
NA
Brief Summary
According to the recommendations of the Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) statement and the Russian guidelines for limb ischemia treatment (2010), rec...
Detailed Description
According to the recommendations of the Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) statement and the Russian guidelines for limb ischemia treatment (2010), rec...
Eligibility Criteria
Inclusion
- Patients with occlusive lesions of C and D type iliac segment and CFA lesion, 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
- Chronic heart failure of III-IV functional class by New York Heart Association (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
- Patient refusal to participate or continue to participate in the study
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03315884
Start Date
December 1 2017
End Date
December 1 2020
Last Update
May 28 2020
Active Locations (1)
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1
NRICP
Novosibirsk, Russia, 630055