Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease II

Peripheral Arterial Disease Clinical Trial

— RAPID II  

Official title:

CorPath® 200 RAPID II Study (Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02742077
• Other study ID #: 2016-01
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: August 2016

Study information

• Verified date: October 2020
• Source: Corindus Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a prospective, single-arm, single center, non-randomized feasibility study of the CorPath 200 System to examine its performance during complete interventions (DCB, Stenting) of the femoropopliteal arteries and patient outcomes at 30 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

General Inclusion Criteria

• 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.

Angiographic Inclusion Criteria Femoropopliteal artery lesion(s) with stenosis (>50%) or occlusion of up to 120 mm in length as determined by imaging (MRA or Angio) prior to index interventional procedure.

Exclusion Criteria:

General Exclusion Criteria

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.

Angiographic Exclusion Criteria

• 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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• Robotic-assisted peripheral vascular intervention
Remote delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventions.

Locations

Country	Name	City	State
Austria	Medizinische Univeristät Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Corindus Inc.

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Adverse Events	No device-related serious adverse events.	Procedure
Secondary	Operator Radiation Exposure Dose	Physician operator radiation exposure as recorded on personal Enterprise Dose Dashboard (EDD; Landauer) dosimeters	Procedure
Secondary	Patient Radiation Exposure Dose	Patient Radiation Dose-area-product (DAP)	Procedure