Primary objective of this study is to assess the treatment outcomes in terms of mobility parameters.Secondary objective is to assess the level of functional status and health-related quality of life.
ID
Source
Brief title
Condition
- Vascular therapeutic procedures
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is to assess the treatment outcomes of percutaneous
revascularization and exercise therapy in terms of mobility parameters.
Secondary outcome
Secondary objective of this study is the level of functional status and
health-related quality of life in patients with disabling intermittent
claudication due to an iliac artery lesion after exercise training or
percutaneous revascularization.
Background summary
The initial treatment of intermittent claudication is exercise therapy and
secondary prevention of cardiovascular disease. This exercise training is
proved to be effective for formation of collaterals. However, in case of an
iliac artery lesion the benefit is not unquestioned. Some practitioners prefer
percutaneous revascularization as the initial treatment. The optimal initial
therapy remains unclear.
Study objective
Primary objective of this study is to assess the treatment outcomes in terms of
mobility parameters.
Secondary objective is to assess the level of functional status and
health-related quality of life.
Study design
A prospective randomized unblinded controlled trial.
Intervention
One group (115 patients) will get percutaneous revascularization.
One group (115 patients) will get supervised exercise training.
All patients will get optimal medical treatment.
Study burden and risks
Patients will be randomized for one out of two treatment groups. Both treatment
strategies are accepted as initial treatment for intermittent claudication. The
risks associated with participating are the normal risks of complication of
treatment, there are no additional risks. Patients are needed to attend three
extra follow-up moments where they are asked to fill in three questionnaires
and some non-invasive hemodynamic measurements will be done. There are no
benefits associated with participating.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
- Age * 18 years
- Disabling claudication as defined by surgeon in discussion with the patient.
- Hemodynamic stenosis of the common or external iliac artery on duplex scanning (PSV ratio * 2.5 or EDV * 0.6 cm/s) or on MRA (> 50% stenosis) or occlusion of the common or external iliac artery on duplex scanning (PSV 0 m/s) or on MRA
- Lesion classified A, B or C according to the TASC classification of aorto-iliac lesions
Exclusion criteria
- Life expectancy < 3 months
- Unable to fill-in self-reported questionnaires (insufficiently reading or speaking the Dutch language, cognitive disorders, etc).
- Legally incompetent adults
- Known contrast allergy
- Pregnancy
- Contra-indication for anticoagulant therapy
- Duration of current complaints < 3 months
- Occlusion of the common femoral artery at the affected side
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL18167.018.07 |