NCT02371785: RAPID

Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease

Completed NA Results posted Last updated 19 March 2019

What this trial tests

NA trial testing CorPath 200 System in Peripheral Arterial Disease in 20 participants. Completed in 22 May 2015.

Timeline

3 February 2015

Primary endpoint
28 April 2015

22 May 2015

Quick facts

Lead sponsor	Corindus Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	3 February 2015
Primary completion	28 April 2015
Estimated completion	22 May 2015
Sites	1 location across Austria

Drugs / interventions tested

• CorPath 200 System

Conditions studied

• Peripheral Arterial Disease — all drugs for Peripheral Arterial Disease →

Sponsor

Corindus Inc.

Who can join

18 and older, any sex, with Peripheral Arterial Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Device Technical Success Primary · Procedure

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

Group	Value	95% CI
CorPath 200 System	29

Adverse Events Primary · Procedure

No device-related serious adverse events during the procedure.

Group	Value	95% CI
Device-related Periprocedural Event	0

Clinical Procedural Success Secondary · 24-hours

Defined as \<50% residual stenosis in all CorPath 200 System treated lesions at the completion of the interventional procedure (without an unplanned switch to the manual procedure) in the absence of device-related SAE, either within twenty-four (24) hours of the procedure or prior to hospital discharge, whichever occurs first.

Group	Value	95% CI
Clinical Procedural Success	20

Fluoroscopy Time Secondary · Procedure

As recorded by an X-ray system utilized during the procedure.

Group	Value	95% CI
Fluoroscopy and/or X-ray Time	6.8	± 3.4

Contrast Volume Secondary · Procedure

Total amount of contrast used during CorPath procedure.

Group	Value	95% CI
Contrast Fluid Volume	73.3	± 9.2

Total Procedure Time Secondary · Procedure

Defined as the time measured from the insertion of the hemostasis sheath until procedure complete (guide catheter removed).

Group	Value	95% CI
Overall Procedure Time	45.5	± 6.2

Interventional Procedure Time Secondary · Procedure

Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.

Group	Value	95% CI
PVI Procedure Time	23.4	± 14.0

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.