At a glance
ClinicalIndex Comparison RecordN/ACompleted· 35 enrolled
Drug / intervention
Shockwave Lithoplasty Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Performance Study of the Shockwave Lithoplasty System
In Brief
A clinical study evaluating Shockwave Lithoplasty System for Peripheral Arterial Disease. Completed, enrolled 35 participants across 3 sites in 3 countries.
Detailed Summary
To study the safety and performance of the Shockwave Medical Lithoplasty System in subjects to demonstrate that the Shockwave device can safely and effectively deliver localized shockwave energy for balloon dilatation of calcified, stenotic, infrainguinal peripheral arteries.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Arterial Disease
CountriesAustria, Germany, New Zealand
Collaborators--
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJan 2014
First PostedFeb 2014
Primary CompletionOct 2014
Study CompletionMar 2015
TodayJul 2026
First PostedFeb 25, 2014
Enrollment StartJan 1, 2014
Primary CompletionOct 1, 2014
Study CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 12.4 years ago
Interventions
Shockwave Lithoplasty Systemdevice