Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease II

NCT02742077 | Completed Results

• 1 other identifier: 2016-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and performance of the CorPath 200 System in the remote delivery and manipulation of guidewires and rapid exchange catheters for use in percutaneous vascular interventions.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

• Clinical Success

  Defined as \<50% residual stenosis in all CorPath 200 System treated lesions at the completion of the interventional procedure in the absence of device-related serious adverse events (SAE).

  72 hours or hospital discharge, whichever comes first.

• Adverse Events

  No device-related serious adverse events.

  Procedure

Secondary Outcomes (2)

• Operator Radiation Exposure Dose

  Procedure

• Patient Radiation Exposure Dose

  Procedure

Study Arms (1)

Robotic-assisted PVI

OTHER

Robotic-assisted peripheral vascular intervention

Device: Robotic-assisted peripheral vascular intervention

Interventions

Robotic-assisted peripheral vascular intervention DEVICE

Remote delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventions.

Robotic-assisted PVI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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 the femoropopliteal arteries; and
• The subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent.

You may not qualify if:

• If any of the following criteria are met, the subject cannot be enrolled in this study:
• Failure/inability/unwillingness to provide informed consent;
• Target vessel has been previously treated with bypass; or
• Enrolled in concurrent clinical study.
• Target vessel:
• Shows evidence of previous dissection or perforation, or
• Has adjacent acute thrombus; or
• Has a pre-existing target artery aneurysm or perforation or dissection of the target artery prior to initiation of the interventional procedure.

Sponsors & Collaborators

• Corindus Inc.: lead

Study Sites (1)

Medizinische Univeristät Graz

Graz, A-8036, Austria

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Results Point of Contact

• Title: Clinical Research Manager
• Organization: Corindus, Inc.

tina.ridgeway@corindus.com

(757) 910-4818

Study Officials

• Marianne Brodmann, MD

  Medizinische Universtität 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: April 12, 2016
• First Posted: April 18, 2016
• Study Start: March 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: August 1, 2016
• Last Updated: November 4, 2020
• Results First Posted: September 4, 2020

Record last verified: 2020-10

Locations

AU (1)