The first prospective registry for patients with symptomatic venous obstructions or occlusions in stented and non-stented veins.
ClinicalTrials.gov Identifier: NCT07529756
Objective
Evaluate real-world patient outcomes after treatment of symptomatic in-stent and native vein occlusions with the Recana System
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Design
- Prospective, non-randomized, multicenter study
- Up to 500 patients
- Core-lab adjudicated imaging
- Standard of care, routine follow-up at 30-day, 6-month, and 1-year post-procedure
Key Enrollment Criteria
- 18 years or older
- Symptomatic lower extremity venous obstructions/occlusions
- Stented and non-stented vessels
- In physician’s opinion, patient could benefit from the Recana
Primary Effectiveness Endpoint
- Restoration of vessel lumen patency
- Lumen diameter gain
- Improvement in patient reported outcomes (quality of life)
Objective
The CALIBER Registry is designed to evaluate real-world patient outcomes following treatment of symptomatic in-stent and native vein occlusions using the Recana System.
The study will provide important evidence on the safety, effectiveness, and patient-centered outcomes in routine clinical practice.
Design
- Prospective, non-randomized, multicenter study
- Up to 500 patients
- Core-lab adjudicated imaging
- Standard of care, routine follow-up at 30-day, 6-month, and 1-year post-procedure
Key Enrollment Criteria
- 18 years or older
- Symptomatic lower extremity venous obstructions/occlusions
- Stented and non-stented vessels
- In physician’s opinion, patient could benefit from the Recana
Primary Effectiveness Endpoint
- Restoration of vessel lumen patency
- Lumen diameter gain
- Improvement in patient reported outcomes (quality of life)
Explore the CALIBER Registry
Click below to explore the CALIBER Registry, view complete study information, or learn how to become a participating study site.