CAPERE Thrombectomy System Post-Market Clinical Follow Up Study

NCT03869645 | Terminated FDA Device

• 1 other identifier: TP18-0009
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 3

Brief Summary

A prospective, single-arm, non-blinded study, intending to collect and evaluate data in up to forty (40) human subjects with acute thrombosis, treated with the CAPERE™ Thrombectomy System.

Conditions

Observational Study

Outcome Measures

Primary Outcomes (1)

• Restoration of blood flow

  Clearance of clot and restoration of venous flow of the affected vessel as confirmed using venogram immediately post-procedure

  Day 0 - Intervention

Secondary Outcomes (5)

• Device Success

  Day 0

• Technical Success Rate

  Day 0

• Thrombus removal rate

  Day 0

• VEINES Survey

  </= Day 0 and Day 30

• Safety Endpoint

  30 days

Interventions

CAPERE Thrombectomy System DEVICE

Mechanical thrombectomy of acute thrombus in peripheral vasculature with the CAPERE Thrombectomy System

Eligibility Criteria

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

Study Population

Adult patients with clinical symptoms of extremity swelling with ultrasound evidence of acute thrombosis in the peripheral vasculature.

You may qualify if:

• Patients who are greater than or equal to 18 years of age
• Patients with clinical signs, symptoms and presentation consistent with acute thrombosis; onset of symptoms \< 14 days
• Patients cleared medically for invasive endovenous procedures

You may not qualify if:

• Patients with IVC filter in area to be treated
• Patients who are \< 18 years of age.
• Known anaphylactic reaction of radiographic contrast agents that cannot be pre- treated
• Imaging evidence or other evidence that suggests the participant is not appropriate for mechanical thrombectomy intervention
• Female who is pregnant or nursing
• Concurrent participation in another investigational drug or device treatment study

Sponsors & Collaborators

• Medtronic Endovascular: lead

Study Sites (3)

Memorial Health Services

Fountain Valley, California, 92708, United States

Location

St. Joseph Hospital

Orange, California, 92868, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Study Officials

• Tiffany Wu, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 7, 2019
• First Posted: March 11, 2019
• Study Start: June 1, 2019
• Primary Completion: August 26, 2020
• Study Completion: August 26, 2020
• Last Updated: September 13, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)