Duplex-guided PTA (DuPTA) versus conventional PTA utilizing contrast in peripheral artery disease: Randomised control trial

Duplex-guided PTA (DuPTA) versus conventional PTA utilizing contrast in peripheral artery disease: Randomised control trial - DuPTA Vs contrast PTA: RCT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38478

Enrollment

142

Registered

2013-05-31

Start date

2013-07-11

Completion date

Unknown

Last updated

2025-03-24

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

Conditions

atherosclerosis Peripheral arterial disease (PAD)

Interventions

Procedure contrast PTA Conventional PTA is not different from current clinical course. Patients report sober in the morning, the day of the planned intervention included the (Day Care / Fasting reco

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Patiënts (above 18 years of age or older) * Indication for PTA in significant stenotic peripheral artery disease

Exclusion criteria

Exclusion criteria: - No duplex-visualization possible - arterial occlusion

Design outcomes

Primary

Measure	Time frame
Primary outcome measure: * Procedural success (passing the stenotic lesion with the guide wire and the dilatation or stenting of the lesion * Clinical success (50% reduction in Peak Systolic Velocity (PSV) or subjectively without symptoms two weeks after the procedure)	—

Secondary

Measure	Time frame
Secondary outcomes: * Duration of intervention (time of puncture - close) * Pain (per-and postoperatively using standardized analog VAS pain score) * Patient satisfaction * complications (bleeding, infection, re-intervention, dissection, for 30 days) * Recovery time (days to full return to work).	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)