Invasive Revascularization or Not in Intermittent Claudication

Intermittent Claudication Clinical Trial

— IRONIC  

Official title:

Invasive Revascularization or Not in Intermittent Claudication

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01219842
• Other study ID #: Sahlgrenska Academy
• Status: Completed
• Phase: N/A
• Start date: March 2010
• Est. completion date: June 2020

Study information

• Verified date: March 2021
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: June 2020
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intermittent Claudication

Intervention

Procedure:
• INVASIVE (INV) treatment
Modern endovascular and/or open revascularisation according to the TASC II recommendations.

Other:
• Best medical treatment (BMT)
Antiplatelet therapy, cilostazol and non-supervised exercise training. Smoking cessation support. Lipid-lowering therapy, diabetes and hypertension treated according to current national guidelines.

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg

Sponsors (2)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden	Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health Related Quality of Life (HRQOL)	Assessed with the patient-reported instruments SF-36, EQ5D and VASCUQOL	24 months with intermistic analysis at 12 months
Secondary	Walking performance on treadmill test	Graded treadmill test with progressively increasing speed and inclination.	24 months with interimistic analysis at 12 months
Secondary	Health Related Quality of Life (HRQOL)	Assessed with the patient-reported instruments SF-36, EQ5D and VASCUQOL	60 months
Secondary	Walking performance on treadmill test	Graded treadmill test with progressively increasing speed and inclination.	60 months
Secondary	six-minutes walk test	Corridor-based walk test during six minutes walk	60 months