|- candidate number||7851|
|- NTR Number||NTR2249|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||19-mrt-2010|
|- Secondary IDs||MEC-2009-432 / NL30125.078.09 METC Erasmus MC|
|- Public Title||Cost-effectiveness of treatment strategies for intermittent claudication: A Multicenter Randomized Controlled Trial.|
|- Scientific Title||Cost-effectiveness of treatment strategies for intermittent claudication: A Multicenter Randomized Controlled Trial.|
|- hypothesis||Endovascular revascularization plus supervised exercise compared to supervised exercise as first-line treatment of patients with intermittent claudication is cost-effective, from the perspectives of the health care system and of society at large, after 1 year follow up.|
|- Healt Condition(s) or Problem(s) studied||Peripheral arterial disease (PAD), Intermittent claudication, Endovascular revascularization, Supervised exercise|
|- Inclusion criteria||1. Rutherford category 1, 2, or 3 (> 3 months duration);|
2. ABI <0.9 at rest or ABI decreasing by >0.15 after treadmill test;
3. Maximum walking distance <500m on a treadmill test (Gardner protocol);
4. 1 or more vascular stenoses of >50% diameter reduction at the iliac or femoro-popliteal level;
5. Informed consent.
|- Exclusion criteria||1. Lesions deemed unsuitable for revascularization; |
2. Abdominal aortic aneurysm >5 cm or iliac aneurysm >1.5 cm;
3. Life-incapacitating cardiac disease (NYHA classification III and higher);
4. Prior treatment for the same lesion (including exercise training);
5. Contra indication for revascularization (allergy to iodinated contrast);
6. Ambulation limited by co-morbid condition;
7. Inability to walk on a tredamill without grade at a speed of at least 3.2 km/h for at least 2 minutes.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2010|
|- planned closingdate||1-mrt-2012|
|- Target number of participants||210|
|- Interventions||1. Intervention group: Endovascular revascularization plus supervised exercise; |
2. Control group: Supervised exercise.
|- Primary outcome||Maximum walking distance.|
|- Secondary outcome||1. Preference based utilities (EQ-5D and Rating Scale);|
2. Health status QoL scores (SF-36 and VascuQol);
4. Maximum painless walking distance;
5. Clinical success;
6. Therapeutic and total costs;
7. CVD risk factor score;
8. Number of events.
|- Timepoints||1. Baseline;|
2. 1, 6 and 12 months follow up.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. S. Spronk|
|- CONTACT for SCIENTIFIC QUERIES||Dr. S. Spronk|
|- Sponsor/Initiator ||ZonMw: The Netherlands Organization for Health Research and Development|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Introduction: Intermittent claudication (IC) is the first symptomatic manifestation of peripheral arterial disease and affects 275 000 people older than 50 years in the Netherlands alone. Despite developments in treatment for IC, the standard treatment is not optimal. This project examines alternative treatments.
Objective of the proposed RCT: To evaluate the cost-effectiveness, from the perspectives of the health care system and of society at large, of supervised exercise compared to endovascular revascularization plus supervised exercise as first-line treatment of IC.
Specific research questions: Comparing endovascular revascularization plus supervised exercise to supervised exercise alone.
1. What is the gain in maximum walking distance (MWD)?
2. What is the gain in quality of life (QoL) and quality adjusted life years (QALYs)?
3. What are the additional costs (or are there cost-savings)?
4. What is the incremental cost-effectiveness ratio?
Study design: Prospective multicenter Randomized Controlled Trial.
Study population: Patients with symptoms of intermittent claudication (Rutherford I,II,III).
1. Supervised exercise at a physical therapy center;
2. Endovascular revascularization plus supervised exercise at a physical therapy center.
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.
Sample size: 210 patients, 1 yr follow-up.
Economic evaluation: In accordance with the Dutch guidelines. We will use the health care perspective and the societal perspective.
|- Main changes (audit trail)|
|- RECORD||19-mrt-2010 - 29-mrt-2010|