The primary objective is to compare initial PTA with supervised exercise therapy for patients with disabling intermittent claudication due to an iliac artery lesion in terms of mobility, functional status, health related quality of life and cost-…
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
The primary objective is to compare initial PTA with supervised exercise
therapy for patients with disabling intermittent claudication due to an iliac
artery lesion with respect to patients* ability to walk and health related
quality of life.
Secondary outcome
Secondary objectives are to assess the level of functional status following
both treatments and to assess the cost-effectiveness and cost-utility of
percutaneous revascularization from a societal perspective with supervised
exercise therapy as the best alternative treatment available.
Background summary
Treatment of patients with IC is aimed at secondary prevention of
cardiovascular events by control of risk factors for atherosclerotic disease,
and to improve walking distance and subsequently quality of life. Supervised
exercise therapy (SET) can effectively improve pain free walking distance.
Percutaneous Transluminal Angioplasty (PTA) as initial therapy is a durable and
an effective treatment for iliac artery obstructions with 4 year patency rates
of 70%. However the most optimal initial therapy for intermittent claudication
due to an iliac artery obstuction is unclear.
Study objective
The primary objective is to compare initial PTA with supervised exercise
therapy for patients with disabling intermittent claudication due to an iliac
artery lesion in terms of mobility, functional status, health related quality
of life and cost- effectiveness.
Study design
A multicenter randomized controlled trial.
Intervention
One group of 200 patient will recieve supervised exercise therapy.
One group of 200 patients will recieve endovascular revascularization.
All patients will recieve 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
\Amsterdam 1100DD
NL
Meibergdreef 9
\Amsterdam 1100DD
NL
Listed location countries
Age
Inclusion criteria
- Age >= 18 years
- Disabling claudication as defined by surgeon based on patient history.
- Ankle/Brachial Index < 0.9 or drop in ABI > 0.15 after exercise test.
- Hemodynamic stenosis of the common or external iliac artery on Color Duplex Scanning (PSV ratio >= 2.5 or EDV >= 0.6 m/s) or on MRA (> 50% stenosis) or occlusion of the common or external iliac artery on Color Duplex Scanning (PSV 0 m/s) or on MRA
- Iliac artery lesion and a concomitant stenosis in the superficial femoral artery defined as stenosis > 50% by Color Duplex Scanning (PSV ratio >= 2.5 or EDV >= 0.6 m/s) or on MRA, or occlusion on DS (PSV 0 m/s) or MRA.
- Lesion classified A, B or C according to the TASC classification of aorto-iliac lesions.
- Patient is able to walk at least 2 minutes on a treadmill at 3.2 km/h and 10% incline
- The Maximum Walking Distance on a treadmill < 300 meters
Exclusion criteria
- Life expectancy < 3 months
- Unable to complete self-reported questionnaires (insufficiently reading or speaking the Dutch language, cognitive disorders, etc).
- 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
- Patient participates in another study
- Heart failure or Angina Pectoris NYHA III or IV.
(NYHA III: Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea
NYHA IV: Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased)
- Patient previously received SET according to KNGF guidelines
- Renal insufficiency (serum creatinin > 150 micromol/l)
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 | NL30212.018.09 |