NCT02371785

Brief Summary

This study evaluates the performance of the CorPath 200 System to deliver guide wires and balloons to blockages in the arteries of the leg.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 3, 2015

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 26, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2015

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2015

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

March 19, 2019

Completed
Last Updated

March 19, 2019

Status Verified

March 1, 2019

Enrollment Period

3 months

First QC Date

February 20, 2015

Results QC Date

September 6, 2018

Last Update Submit

March 18, 2019

Conditions

Peripheral Arterial Disease

Keywords

Peripheral Arterial DiseaseCritical Limb IschemiaClaudicationPercutaneous Vascular InterventionPeripheral Vascular Intervention

Outcome Measures

Primary Outcomes (2)

  • Device Technical Success

    Number of lesions for which there was technical success" as accurate and appropriate.

    Procedure

  • Adverse Events

    No device-related serious adverse events during the procedure.

    Procedure

Secondary Outcomes (5)

  • Clinical Procedural Success

    24-hours

  • Fluoroscopy Time

    Procedure

  • Contrast Volume

    Procedure

  • Total Procedure Time

    Procedure

  • Interventional Procedure Time

    Procedure

Study Arms (1)

CorPath 200 System

EXPERIMENTAL

CorPath 200 System for remote delivery and manipulation of guidewires and balloon catheters during percutaneous vascular intervention.

Device: CorPath 200 System

Interventions

CorPath 200 SystemDEVICE

Remote delivery of guide wires and balloon catheters for use in percutaneous vascular interventions (PVI).

CorPath 200 System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 years of age;
  • Symptomatic disease: presence of critical limb ischemia (including tissue loss or rest pain), or lifestyle-limiting claudication requiring intervention in iliac and/or superficial femoral arteries;
  • The subject or the legally authorized representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent.
  • Presence of superficial femoral artery and/or iliac stenosis (\>50%) or occlusion of up to 50 mm in length as determined by angiogram prior to index interventional procedure.

You may not qualify if:

  • Failure/inability/unwillingness to provide informed consent;
  • Target vessel has been previously treated with bypass;
  • Has an abdominal aortic aneurysm contiguous with the iliac artery target lesion;
  • Has contraindication to anticoagulation;
  • Has bleeding or a hypercoagulability disorder;
  • Thrombocytopenia;
  • Elevated international normalized ratio (\>1.5);
  • Elevated serum creatinine (≥2.5 mg/dL);
  • Active infection;
  • Contraindication to contrast; or
  • Enrolled in concurrent clinical study.
  • Target vessel:
  • shows evidence of previous dissection or perforation, or
  • has adjacent acute thrombus;
  • Lesion is highly calcified;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medizinische Univeristät Graz

Graz, A-8036, Austria

Location

MeSH Terms

Conditions

Peripheral Arterial DiseaseChronic Limb-Threatening IschemiaIntermittent Claudication

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsIschemiaSigns and Symptoms

Limitations and Caveats

This study represents a single high-volume tertiary care center experience and the results need to be replicated by multiple users to show the general applicability of these findings.

Results Point of Contact

Title
Vice President, Clinical and Regulatory Affairs
Organization
Corindus Vascular Robotics
john.vanvleet@corindus.com
260-615-8892

Study Officials

  • Marianne Brodmann, M.D.

    Medizinische Universität Graz

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2015

First Posted

February 26, 2015

Study Start

February 3, 2015

Primary Completion

April 28, 2015

Study Completion

May 22, 2015

Last Updated

March 19, 2019

Results First Posted

March 19, 2019

Record last verified: 2019-03

Locations

AU(1)