NCT03970538

PROMISE II: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia

Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia: the PROMISE II Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: LimFlow, Inc. · Industry
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

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").

Detailed description

The objective of this US pivotal trial is to investigate the safety and effectiveness of The LimFlow System for creating an AV connection in the Below The Knee (BTK) vascular system using an endovascular, minimally invasive approach to arterialize the pedal veins for the treatment of chronic limb-threatening ischemia (CLTI) in subjects ineligible for conventional endovascular or surgical limb salvage procedures.

Conditions

• Critical 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

Interventions

Type	Name	Description
DEVICE	LimFlow System	Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia

Timeline

• Start date: 2019-12-06
• Primary completion: 2022-09-09
• Completion: 2025-02-28
• First posted: 2019-05-31
• Last updated: 2024-02-28
• Results posted: 2024-02-28

Locations

21 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated device study