At a glance
ClinicalIndex Comparison RecordN/ACompleted· 50 enrolled
Drug / intervention
DCB +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.
Randomized Study of IN.PACT 014 Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter vs. Optimal Percutaneous Transluminal Angioplasty for the Treatment of Chronic Total Occlusions in the Infrapopliteal Arteries
In Brief
A clinical study evaluating DCB and PTA for Critical Limb Ischemia and Peripheral Arterial Disease. Completed, enrolled 50 participants across 9 sites in 5 countries.
Detailed Summary
To assess the safety and efficacy of the paclitaxel drug-coated balloon IN.PACT 014 versus conventional optimal percutaneous transluminal angioplasty (PTA) for the treatment of patients with chronic total occlusions in the infrapopliteal arteries.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, France, Greece, Italy, Switzerland
Collaborators--
Timeline
N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedNov 2016
Enrollment StartMar 2017
Primary CompletionOct 2019
Study CompletionDec 2023
TodayJul 2026
First PostedNov 15, 2016
Enrollment StartMar 2, 2017
Primary CompletionOct 7, 2019
Study CompletionDec 21, 2023
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 9.6 years ago
Interventions
DCBdevice
Drug Coated Balloon
PTAdevice
Percutaneous Transluminal Angioplasty