The ReCAna for Lower ExtremIty Venous OBstructions and In-StEnt Restenosis Registry (NCT07529756) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The ReCAna for Lower ExtremIty Venous OBstructions and In-StEnt Restenosis Registry
87 participantsStarted 2026-06
Plain-language summary
The goal of this observational study is to gather additional safety and performance (effectiveness) data on the device for the treatment of symptomatic lower extremity venous obstructions and occlusions. The main questions the study aims to answer are:
* What is the observed rate of safety events through the 30-day follow-up?
* What is the rate of technical success (acute procedural success) achieved at the index procedure?
Participants already undergoing treatment with the Recana as part of their regular medical care will be followed for 1 year.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. INC-1: Subject is 18 years or older
✓. INC-2: Proximal lower extremity obstruction/occlusion involving the femoral, common femoral, iliac veins, or inferior vena cava (IVC), alone or in combination that in the opinion of the investigator, treatment with the Recana would benefit the patient
✓. INC-3: Recana Thrombectomy Catheter System must enter vasculature
✓. INC-4: Willing and able to provide written informed consent
✓. INC-1: Subject is 18 years or older
✓. INC-2: Subjects with stents implanted greater than 6 weeks prior to index procedure
✓. INC-3: Location of thrombosed stents in proximal lower extremity deep vein segments including common femoral, external iliac, common iliac vein, or inferior vena cava alone or in combination that in the opinion of the investigator treatment with the Recana would benefit the patient
✓. INC-4: Recana Thrombectomy Catheter System must enter vasculature
Exclusion criteria
✕. EXC-1: IVC aplasia/hypoplasia or other congenital anatomic anomalies of the IVC or iliac veins
✕. EXC-2: IVC filter in place at the time of index procedure that, in the judgment of the investigator, may interfere with the procedure
✕. EXC-3: Congenital anatomic anomalies of the iliac veins that in the opinion of the investigator would preclude treatment with the Recana
What they're measuring
1
Composite of Major Adverse Events (MAE)
Timeframe: From Index Procedure (Day 0) to 30-Days Post-Procedure
✕. EXC-4: Heparin allergy or hypersensitivity that cannot be adequately managed with alternate anticoagulant during or after the procedure, or prior diagnosis of HIT (Heparin-Induced Thrombocytopenia)
✕. EXC-5: Severe, life-threatening allergy to iodine or contrast dye
✕. EXC-6: Any contraindication to anticoagulants or antiplatelets that, in the opinion of the Investigator, cannot be medically managed throughout the study period
✕. EXC-7: Life expectancy less than 1 year
✕. EXC-8: Chronic non-ambulatory status such as long-term wheelchair requirement or bedridden status