Invasive Revascularization or Not in Intermittent Claudication

Not Applicable

Completed

• Conditions: Intermittent Claudication
• Interventions: Other: Best medical treatment (BMT); Procedure: INVASIVE (INV) treatment

• Registration Number: NCT01219842
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

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 identified only limited evidence for the effectiveness of invasive treatment for IC in patients already on exercise training. The prognosis for the extremity is usually benign and treatment therefore aims at improving quality of life. Invasive treatment can also cause serious complications. Coronary artery disease is common in IC patients increasing the risk with invasive treatment. In spite of these uncertain merits and potential risks, invasive procedures for IC are increasing and 37% of all invasive procedures for PAD in Sweden are performed for IC. The aim of this study is to evaluate the additional effects of modern invasive treatment in patients with intermittent claudication receiving modern best medical treatment (BMT). The primary hypothesis in the study is that invasive treatment in addition to BMT improves health related quality of life and walking performance compared to BMT only.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-10-12
• Study First Submitted QC: 2010-10-12
• Study First Posted: 2010-10-13
• Primary Completion: 2014-12
• Study Completion: 2020-06
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-17
• Last Update Posted: 2021-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

Inclusion Criteria

• Patient with intermittent claudication (typical symptoms and ABI <0.9) seeking treatment
• Significant aortoiliac- and/or femoropopliteal lesion.
• Age 30-80 years

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NON-INVASIVE (NON) group	Best medical treatment (BMT)	Patients receiving only best medical treatment (BMT).
INVASIVE (INV) group	INVASIVE (INV) treatment	Modern endovascular and/or open revascularization according to the recommendations in the TASC II document.
INVASIVE (INV) group	Best medical treatment (BMT)	Modern endovascular and/or open revascularization according to the recommendations in the TASC II document.

Primary Outcome Measures

Name	Time	Method
Health Related Quality of Life (HRQOL)	24 months with intermistic analysis at 12 months	Assessed with the patient-reported instruments SF-36, EQ5D and VASCUQOL

Secondary Outcome Measures

Name	Time	Method
Walking performance on treadmill test	60 months	Graded treadmill test with progressively increasing speed and inclination.
Health Related Quality of Life (HRQOL)	60 months	Assessed with the patient-reported instruments SF-36, EQ5D and VASCUQOL
six-minutes walk test	60 months	Corridor-based walk test during six minutes walk

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden