Our aim is to evaluate the patency of cryoplasty in patients with intermittent claudication or critical ischemia, where exercise training is ineffective. Furthermore, we will evaluate whether cryoplasty will significantly improve the quality of life…
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
12 months patency of cryoplasty and PTA. No reintervention, no amputation, no
significant restenosis or occlusion at duplex ultrasound
Secondary outcome
Direct technical success (maximum of 30% stenosis), relief of symptoms,
improvement in quality of life, complications of the procedure (< 24 hrs and <
30 days). Complications include occlusion and thrombosis of the treated leg,
distal emboli, death, stroke, myocardial infarction and acute surgical
reintervention.
Background summary
Atherosclerotic occlusive disease of the femoropopliteal arteries is a leading
cause of intermittent claudication and critical ischemia. There are several
treatment options. The initial treatment is exercise training to promote
collateral circulation in the leg. A disadvantage of this treatment is the
limited and relative late effect. A surgical option is creating a bypass in the
upper leg. This is a relative invasive treatment option with limited patency
when using prosthetic material. Another possibility is endovascular treatment
using percutanous transluminal angioplasty (PTA) balloons and stents. PTA is
frequently offered as the initial treatment for intermittent claudiation
elsewhere. Advantages are low mortality and morbidity rates, low costs and high
initial technical success (90%) of the procedure. A disadvantage is the
relative low primary patency with restenoses of the treated vessel frequently
occurring within the first year. A recently developed endovascular technique,
cryoplasty, combines the dilatation of PTA with delivery of cold thermal energy
to the vessel wall. This should promote *positive remodeling* of the vessel
wall after PTA and increase the patency of the procedure. Patients with
intermittent claudication could hereby be offered a treatment therapy with
instant and longer lasting relief of their symptoms.
Study objective
Our aim is to evaluate the patency of cryoplasty in patients with intermittent
claudication or critical ischemia, where exercise training is ineffective.
Furthermore, we will evaluate whether cryoplasty will significantly improve the
quality of life and give relief of symptoms for a long period of time.
Study design
A randomised single center study
Intervention
Percutanous transluminal angioplasty (PTA) with conventional balloons or with
cryoplasty balloons of the femoropopliteal arteries.
Study burden and risks
Risks include dissection of the vessel wall of the treated segment (7% to 15%).
Occasionally distal emboli can occur. Because of the arterial puncture there is
a chance of a haematoma in the groin (5%) and occasionally a false aneurysm or
AV fistula (2%). Papers published on cryoplasty report a relatively low
dissection rate of cryoplasty.
Albert Schweitzerplaats 25 Postbus 444
3300 AK Dordrecht
Nederland
Albert Schweitzerplaats 25 Postbus 444
3300 AK Dordrecht
Nederland
Listed location countries
Age
Inclusion criteria
Patients with intermittent claudication or critical ischemia with occlusive disease of the femoropopliteal arteries, where conservative treatment is ineffective.
Exclusion criteria
Adverse effects of contrast agents in the past
Expected lifespan less than one year
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 | NL13969.101.06 |