CompletedNot Applicable

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)

Russia202 participantsStarted 2015-08

Plain-language 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.

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 30 days

Evaluation of efficiency: primary patency, secondary patency success of procedures, length of hospital stay

Timeframe: 30 days

Evaluation of efficiency: success of procedures

Timeframe: 30 days

Trial details

NCT IDNCT02580084

SponsorMeshalkin Research Institute of Pathology of Circulation

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2017-08

View on ClinicalTrials.gov More Atherosclerosis of the Peripheral Arteries trials

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Timeframe: 30 days

Evaluation of efficiency: primary patency, secondary patency success of procedures, length of hospital stay

Timeframe: 30 days

Evaluation of efficiency: success of procedures

Timeframe: 30 days