At a glance
ClinicalIndex Comparison RecordN/ACompleted· 51 enrolled
Drug / intervention
Orbital Atherectomy System +1 moredevice
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.
Complete Lesion Assessment With ffR and IVUS TechnologY (CLARITY I)
In Brief
A clinical study evaluating Orbital Atherectomy System and Balloon Angioplasty for Peripheral Artery Disease and Critical Limb Ischemia. Completed, enrolled 51 participants across 8 sites.
Detailed Summary
CLARITY I is a pilot study to identify the clinically appropriate endpoint(s) of a larger, statistically powered pivotal trial for treatment of patients with Critical Limb Ischemia (CLI).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Artery Disease, Critical Limb Ischemia
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2013
First PostedSep 2013
Primary CompletionJun 2015
TodayJul 2026
First PostedSep 13, 2013
Enrollment StartMar 1, 2013
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 12.8 years ago
Interventions
Orbital Atherectomy Systemdevice
Orbital atherectomy (OA) is performed prior to adjunctive balloon angioplasty (BA)
Balloon Angioplastydevice
Type of balloon selected is driven by preference of the operator.