CAPERE Thrombectomy System Post-Market Clinical Follow Up... | NCT03869645

Studies
CAPERE Thrombectomy System Post-Market Clinical Follow Up Study

NCT03869645

Sponsor

Medtronic Endovascular

Status

Terminated

Last Update Posted

Sep 13, 2022Actual

Enrollment

18Actual

Phase

Not provided

Conditions

Observational Study

Interventions

CAPERE Thrombectomy System

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Change in Sponsor

Expanded Access Info

Start Date

Jun 1, 2019Actual

Primary Completion Date

Aug 26, 2020Actual

Completion Date

Aug 26, 2020Actual

First Submitted Date

Mar 7, 2019

First Submission Date that Met QC Criteria

Mar 8, 2019

First Posted Date

Mar 11, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 8, 2022

Last Update Posted Date

Sep 13, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Subjects will be evaluated based on VEINES QoL survey pre- and post-treatment (30-days).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CAPERE Thrombectomy System	Device	Mechanical thrombectomy of acute thrombus in peripheral vasculature with the CAPERE Thrombectomy System

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Device Success	Successful withdrawal of device along with clots without clinically significant emboli, permanent vessel trauma, entry site aneurysm, major bleeding complications	Day 0
Technical Success Rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tiffany Wu, MD	Unity Health Toronto	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Memorial Health Services		Fountain Valley	California	92708	United States
St. Joseph Hospital

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided