Cryoplasty of the femoropopliteal arteries in patients with intermittent claudication compared with conventional angioplasty: a randomized study

Cryoplasty of the femoropopliteal arteries in patients with intermittent claudication compared with conventional angioplasty: a randomized study - Cryoplasty of the femoropopliteal arteries

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29719

Enrollment

100

Registered

2006-10-17

Start date

2007-08-02

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerotic occlusive disease. Vessel occlusion.

Interventions

Percutanous transluminal angioplasty (PTA) with conventional balloons or with cryoplasty balloons of the femoropopliteal arteries.

Sponsors

Albert Schweitzer Ziekenhuis

Lead Sponsor

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with intermittent claudication or critical ischemia with occlusive disease of the femoropopliteal arteries, where conservative treatment is ineffective.

Exclusion criteria

Exclusion criteria: Adverse effects of contrast agents in the past Expected lifespan less than one year

Design outcomes

Primary

Measure	Time frame
12 months patency of cryoplasty and PTA. No reintervention, no amputation, no significant restenosis or occlusion at duplex ultrasound	—

Secondary

Measure	Time frame
Direct technical success (maximum of 30% stenosis), relief of symptoms, improvement in quality of life, complications of the procedure (	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)