The ReCAna for Lower ExtremIty Venous OBstructions and In-StEnt Restenosis Registry

NCT07529756 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: CLN015
• Study Type: observational
• Target: 87
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Venous Disease; Chronic Venous Insufficiency, CVI; Venous Thrombosis; Thrombosis (Stent Thrombosis); Thrombosis, Venous; Embolism and Thrombosis; Thrombectomy

Keywords

in-stent restenosis; venous obstruction or occlusion; thrombus; emboli; CALIBER Registry; recanalization; debulking

Outcome Measures

Primary Outcomes (2)

• Composite of Major Adverse Events (MAE)

  Composite of Major Adverse Events (MAE) where MAE is a combined clinical endpoint of death (all-cause mortality), major bleeding, and symptomatic pulmonary embolism

  From Index Procedure (Day 0) to 30-Days Post-Procedure

• Technical Success (Acute Procedural Success)

  * In-stent restenosis (ISR) venous segment: defined as patency ≥50% luminal diameter utilizing IVUS * Native venous segment: defined as patency ≥50% luminal diameter utilizing IVUS

  Index Procedure (Day 0)

Secondary Outcomes (10)

• Incidence rates of the following: (1) Individual components of the MAE composite endpoint; (2) Minor bleeding; and (3) Access site complications from the index procedure (hematoma, false aneurysm, perforation)

  From Index Procedure (Day 0) to 30-Days Post-Procedure

• Incidence rate of device-related death

  From Index Procedure (Day 0) through study completion assessed up to 365-days post-procedure

• Incidence rate of procedure-related death

  From Index Procedure (Day 0) through study completion assessed up to 365-days post-procedure

• Patency rates of Target Venous Segment (TVS)

  From Index Procedure (Day 0) through study completion assessed up to 365-days post-procedure

• Incidence rate of device-related rethrombosis of the Target Venous Segment (TVS)

  From Index Procedure (Day 0) through study completion assessed up to 365-days post-procedure

Other Outcomes (8)

• Additional Safety Outcome Measures through 30-days post-procedure in the Primary Analysis Set (PAS) Population

  From Index Procedure (Day 0) through 30-Days Post-Procedure

• Additional Safety Outcome Measures through 365-days post-procedure in the Primary Analysis Set (PAS) Population

  From Index Procedure (Day 0) through study completion assessed up to 365-days post-procedure

• Post-procedural average effective stent diameter (percent) in the Primary Analysis Set (PAS) Population

  Immediately after the intervention/procedure (Day 0)

Study Arms (3)

Primary Analysis Set (PAS) Population

The Primary Analysis Set (PAS) population is a subset of the Full Analysis Set (FAS) population with unilateral or bilateral venous obstructions or occlusions without recent (≤3 months) venous intervention. The first 87 subjects in the FAS population who meet these criteria will complete the Primary Analysis Set population.

Device: Recanalization and debulking

Full Analysis Set (FAS) Population

The Full Analysis Set (FAS) population is defined as all consented subjects who are determined to be are appropriate candidates for treatment with the Recana Thrombectomy Catheter System and undergo the study procedure. The study will consist of up to 500 subjects in the FAS population.

Device: Recanalization and debulking

Intention to Treat (ITT) Population

The Intention-to-Treat (ITT) population is defined as all consented subjects who are determined to be candidates for treatment with the Recana Thrombectomy Catheter System, independent of the procedure being initiated or completed.

Interventions

Recanalization and debulking DEVICE

Recanalization and debulking with the Recana Thrombectomy Catheter System

Full Analysis Set (FAS) Population; Primary Analysis Set (PAS) Population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Potential subjects with symptomatic lower extremity obstruction/occlusion

INCLUSION CRITERA: A. Native Vessel: 1. INC-1: Subject is 18 years or older 2. 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 3. INC-3: Recana Thrombectomy Catheter System must enter vasculature 4. INC-4: Willing and able to provide written informed consent B. In-Stent Restenosis: 1. INC-1: Subject is 18 years or older 2. INC-2: Subjects with stents implanted greater than 6 weeks prior to index procedure 3. 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 4. INC-4: Recana Thrombectomy Catheter System must enter vasculature 5. INC-5: Willing and able to provide written informed consent EXCLUSION CRITERA A. Native Vessel: 1. EXC-1: IVC aplasia/hypoplasia or other congenital anatomic anomalies of the IVC or iliac veins 2. EXC-2: IVC filter in place at the time of index procedure that, in the judgment of the investigator, may interfere with the procedure 3. EXC-3: Congenital anatomic anomalies of the iliac veins that in the opinion of the investigator would preclude treatment with the Recana 4. 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) 5. EXC-5: Severe, life-threatening allergy to iodine or contrast dye 6. EXC-6: Any contraindication to anticoagulants or antiplatelets that, in the opinion of the Investigator, cannot be medically managed throughout the study period 7. EXC-7: Life expectancy less than 1 year 8. EXC-8: Chronic non-ambulatory status such as long-term wheelchair requirement or bedridden status 9. EXC-9: Known hypercoagulable states that, in the opinion of the investigator, cannot be medically managed throughout the study period 10. EXC-10: Inability to secure venous access and cross lesion 11. EXC-11: Subject has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject 12. EXC-12: Current active participation in another investigational drug or device study in which the primary endpoint has not been analyzed B. In-Stent Restenosis: 1. EXC-1: Exposed stents with broken struts, significantly deformed struts, struts protruding into the vessel 2. EXC-2: Stent failure caused by undersizing or malapposition of the stent(s) \[For example, the segment of a stent in the iliac vein that is not wall apposed or cannot be apposed to the wall after balloon dilation is excluded. The segment of a stent that extends into the IVC that is not wall apposed would not be excluded.\] 3. EXC-3: Stents compressed to \<6mm that remain \<6mm after balloon dilation 4. EXC-4: IVC filter in place at the time of index procedure that, in the judgment of the investigator, may interfere with the procedure 5. EXC-5: Congenital anatomic anomalies of the iliac veins that in the opinion of the investigator would preclude treatment with the Recana 6. EXC-6: 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) 7. EXC-7: Severe, life-threatening allergy to iodine or contrast dye 8. EXC-8: Any contraindication to anticoagulants or antiplatelets that, in the opinion of the Investigator, cannot be medically managed throughout the study period 9. EXC-9: Life expectancy less than 1 year 10. EXC-10: Chronic non-ambulatory status such as long-term wheelchair requirement or bedridden status 11. EXC-11: Known hypercoagulable states that, in the opinion of the Investigator, cannot be medically managed throughout the study period 12. EXC-12: Inability to secure venous access and cross lesion 13. EXC-13: Subject has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject 14. EXC-14: Current active participation in another investigational drug or device study in which the primary endpoint has not been analyzed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Intervene, Inc.: lead

MeSH Terms

Conditions

Blindness, Cortical; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Bites and Stings; Embolism

Condition Hierarchy (Ancestors)

Blindness; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• William A Marston, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

• Kush R Desai, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Sameh Sayfo, MD, MBA

  Baylor Scott & White The Heart Hospital - Plano

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Affairs Team

CONTACT

650-995-7137; ClinSupport@intervene-med.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: April 14, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share