Status:
COMPLETED
Invasive Revascularization or Not in Intermittent Claudication
Lead Sponsor:
Sahlgrenska University Hospital
Collaborating Sponsors:
Göteborg University
Conditions:
Intermittent Claudication
Eligibility:
All Genders
30-80 years
Phase:
NA
Brief Summary
Peripheral arterial disease (PAD) often causes exertion pain in the legs, intermittent claudication (CI) affecting\> 10% of individuals\> 65 years. A recent Swedish Health Technology Assessment Report...
Eligibility Criteria
Inclusion
- Patient with intermittent claudication (typical symptoms and ABI \<0.9) seeking treatment
- Significant aortoiliac- and/or femoropopliteal lesion.
- Age 30-80 years
Exclusion
- Invasive treatment contraindicated because of severe intercurrent disease.
- Two or more failed vascular reconstructions in the same leg.
- Employees unable to work because of intermittent claudication.
- Need for open reconstruction below the tibioperoneal trunc.
- Thromboembolic etiology (popliteal artery aneurysm; cardiac emboli)
- Other disease severely affecting walking performance.
- Body weight \> 120 kilograms.
- Age \<30 or \> 80 years.
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2020
Estimated Enrollment :
159 Patients enrolled
Trial Details
Trial ID
NCT01219842
Start Date
March 1 2010
End Date
June 1 2020
Last Update
March 18 2021
Active Locations (1)
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1
Sahlgrenska University Hospital
Gothenburg, Sweden, 413 45