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Cost-effectiveness of treatment strategies for intermittent claudication

Cost-effectiveness of treatment strategies for intermittent claudication - Cost-effectiveness of treatment strategies for intermittent claudication

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35031
Enrollment
210
Registered
2010-01-12
Start date
2010-08-01
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

Intermittent claudication (IC)

Interventions

1. Supervised exercise at a physical therapy center
2. Endovascular revascularization plus supervised exercise at a physical therapy center

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Rutherford category 1, 2, or 3 2. Maximum pain-free walking distance 0.15 after the treadmill test; 4. >=1 vascular stenoses of >50% diameter reduction at the iliac or femoro-popliteal level. 5. Informed consent

Exclusion criteria

Exclusion criteria: 1. Abdominal aortic aneurysm 2. Life-incapacitating cardiac disease (NYHA classification III and higher); 3. Multilevel disease (i.e., same-side stenoses at both the iliac and femoral levels, requiring multiple revascularization procedures) 4. Isolated tibial artery disease 5. Lesions deemed unsuitable for revascularization 6. Prior treatment for the same lesion (including exercise training)

Design outcomes

Primary

MeasureTime frame
Primary: maximum walking distance; Secondary: preference based utilities (EQ-5D and Rating Scale), health status QoL scores (SF-36 and VascuQol), ABI, maximum painless walking distance, clinical success, therapeutic and total costs, CVD risk factor score, number of events; all outcomes after 1-, 6-, and 12-months follow-up.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)