At a glance
ClinicalIndex Comparison RecordN/AUnknown· 105 enrolled
Drug / intervention
LimFlow 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.
Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia: the PROMISE II Trial
In Brief
A clinical study evaluating LimFlow System for Critical Limb Ischemia and 11 related conditions. Targeting 105 participants across 21 sites in 2 countries.
Detailed Summary
The LimFlow System is intended for endovascular, minimally invasive procedures in patients who have a clinical diagnosis of chronic limb-threatening ischemia and who have been determined to have no surgical or endovascular treatment option (i.e., "no option").
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCritical Limb Ischemia, Critical Lower Limb Ischemia, Peripheral Artery Disease, Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia, Arterial Occlusive Diseases, Arterial Occlusion, Arterial Disease, Peripheral Artery Occlusion, Peripheral Vascular Disease, Peripheral Ischemia, Vascular Diseases
CountriesPuerto Rico, United States
Collaborators--
Timeline
N/AUnknownOverdue
2020202120222023202420252026
First PostedMay 2019
Enrollment StartDec 2019
Primary CompletionSep 2022
Study CompletionFeb 2025
TodayJul 2026
First PostedMay 31, 2019
Enrollment StartDec 6, 2019
Primary CompletionSep 9, 2022
Study CompletionFeb 28, 2025
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 7.1 years ago
Interventions
LimFlow Systemdevice
Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia