patients with symptoms of IC stage I-III (Rutherford).
Conditions
Interventions
Percutaneous transluminal angioplasty:
PTA is an invasive procedure with catheterisation and digital subtraction angiography (DSA). The procedure requires an arterial puncture and a 4-6 hour period o
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: Patients with: 1. Symptoms of IC of at least 3 months duration; 2. ABI of less than 0.9 in rest or with a decrease in ABI after the treadmill test of more than 30%; 3. Symptoms of IC with one or more lesions on imaging work-up at : a. Iliac level suitable for angioplasty (TASC (TransAtlantic Inter Society Consensus) type A, B or C), as agreed upon by the vascular surgeons and interventional radiologists; b. Femoro-popliteal level suitable for angioplasty (TASC type A, B or C), as agreed upon by the vascular surgeons and interventional radiologists; 4. A MPWD of less than 350m; 5. Informed consent.
Exclusion criteria
Exclusion criteria: Patients with: 1. Walking limitations because of co-morbidities, such as angina pectoris, congestive heart failure, chronic obstructive pulmonary disease, arthritis; 2. Walking limitations because of immobility, caused by a prior CVA or amputation of a limb; 3. Contraindications for the use of iodinated contrast media.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life during follow-up: The aim of exercise training and PTA in patients with intermittent claudication is to improve the patients’quality of life and this will be the primary outcome of the study. A difference in improvement has to be demonstrated in the four therapeutic strategies. MPWD after 6 months and one year follow up: The goal of exercise training and percutaneous transluminal angioplasty is improvement of MPWD. The percentage change in progression of the MPWD will be a primary outcome of this study. Costs of therapy: The costs of the different therapeutic strategies will be tracked. Costs of the different therapeutic procedures will be determined with cost-accounting taking into account the investment of equipment in the angiography room and equipment in the vascular laboratory, investments during use, maintenance, years of use, number of procedures per year and personnel costs ( specially for hospital-based exercise). The time costs for the patients will be measured by tracking the time patients spend waiting for procedures in the hospital, exercising, and the time during the procedures. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cross-overs from conservative exercise training to revascularisation; 2. Cross-overs from revascularisation to conservative exercise training; 3. Lifestyle changes (e.g. quit smoking, do more exercise, lose weight); 4. Trend over time in the percentage of eligible patients recruited for randomisation. As long as there is true equipoise with respect to which therapeutic strategy is optimal, both physicians and patients will feel no discomfort with patients being randomised across the four therapeutic work-up strategies. If, over time it becomes clear from clinical experience that using one of the four therapeutic strategies is preferable, physicians will be reluctant to recruit patients for the trial and patients will be unwilling to participate. This should be noticeable in the recruitment rate. Thus, the percentage eligible patients recruited over time will be tracked; 5. Event-free survival at 6 months and one year after randomisation. With an event defined as failure of the exercise programme because of co-morbidities, failure of the PTA procedure, failure to improve symptoms, restenosis, residual stenosis and complications due to the PTA procedure; 6. Number of events and all-cause mortality during follow-up; 7. ABI in rest and after a treadmill test (after PTA), after 6 months and after one year follow up; 8. Diagnostic imaging of the dilated arterial segment in case of recurrent symptoms. | — |
Contacts
Public ContactS. Spronk
Ikazia Hospital, Department of Surgery, Montessoriweg 1
Outcome results
None listed