Minimal invasive balloon expansion versus bypass operation to treat complicated occlusions and stenoses of the femoral and popliteal arteries

Stent versus bypass for femoropopliteal TASC II Type C and D lesions: a prospective randomised trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18315574

Enrollment

218

Registered

2016-04-29

Start date

2016-03-08

Completion date

Unknown

Last updated

2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis Circulatory System Peripheral arterial occlusive disease of the lower extremity

Interventions

Patients are allocated to one of two groups by computer generated randomizing. Block variables are TASC C lesions, TASC D lesions, Fontaine Stage IIb (intermittent claudication) and Fontaine Stage III

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 30 years and over 2. Peripheral arterial occlusive disease of the lower extremity due to atherosclerosis 3. Disabling claudication (walking distance < 200 m) or critical ischemia (rest pain and/or tissue loss) 4. Radiologically verified long lesions (TASC II Type C or D) of the femoral and/or politeal artery 5. Symptoms for more than 2 months 6. Unimpaired ipsilateral iliac arteries 7. Capacity to provide informed consent

Exclusion criteria

Exclusion criteria: 1. Acute ischemia 2. Embolic occlusion of the femoropopliteal segment 3. Trauma 4. Non-disabling claudication (walking distance > 200 m) 5. Radiologically verified short femoropopliteal lesions (TASC II Type A and B) 6. Vasculitis 7. Renal insufficiency (glomerular filtration rate 3

Design outcomes

Primary

Measure	Time frame
1. Technical success is measured using control angiography at the end of the procedure 2. Primary and secondary patency is measured using clinical examination and ultrasound examination at baseline, 2 weeks, 4 weeks, 3 months, 6 months and 12 months	—

Secondary

Measure	Time frame
1. Local complications (e.g. surgical site infection, bleeding) are measured using clinical and ultrasound examination at baseline, 2 weeks, 4 weeks, 3 months, 6 months and 12 months. If extensive local complications computed tomography angiography is performed. For surgical site infections blood samples and samples for bacterial culture are taken. 2. Systemic complications (e.g. myocardial infarction, stroke) are measured using clinical examinations at baseline, 2 weeks, 4 weeks, 3 months, 6 months and 12 months 3. Limb salvage rate is determined using Kaplan Meier estimation at the end of the study 4. Survival rate is determined using Kaplan Meier estimation at the end of the study 5. Costs are calculated by the hospital's accounting department at the end of the study	—

Measure

Time frame

1. Local complications (e.g. surgical site infection, bleeding) are measured using clinical and ultrasound examination at baseline, 2 weeks, 4 weeks, 3 months, 6 months and 12 months. If extensive local complications computed tomography angiography is performed. For surgical site infections blood samples and samples for bacterial culture are taken. 2. Systemic complications (e.g. myocardial infarction, stroke) are measured using clinical examinations at baseline, 2 weeks, 4 weeks, 3 months, 6 months and 12 months 3. Limb salvage rate is determined using Kaplan Meier estimation at the end of the study 4. Survival rate is determined using Kaplan Meier estimation at the end of the study 5. Costs are calculated by the hospital's accounting department at the end of the study

—

Countries

Austria

Contacts

Public ContactKlaus Linni

k.linni@salk.at+43 662 4482 53201

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 6, 2026