Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02371785
• Date of registration: 20/02/2015
• Prospective Registration: No
• Primary sponsor: Corindus Inc.
• Public title: Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease RAPID
• Scientific title: Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease
• Date of first enrolment: February 3, 2015
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02371785
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Austria

Contacts

• Name: Marianne Brodmann, M.D.
• Affiliation: Medizinische Universität Graz

Key inclusion & exclusion criteria

Inclusion Criteria:

- General Inclusion

1. At least 18 years of age;

2. 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;

3. 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.

- Angiographic Inclusion

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.

Exclusion Criteria:

- General Exclusion

1. Failure/inability/unwillingness to provide informed consent;

2. Target vessel has been previously treated with bypass;

3. Has an abdominal aortic aneurysm contiguous with the iliac artery target lesion;

4. Has contraindication to anticoagulation;

5. Has bleeding or a hypercoagulability disorder;

6. Thrombocytopenia;

7. Elevated international normalized ratio (>1.5);

8. Elevated serum creatinine (=2.5 mg/dL);

9. Active infection;

10. Contraindication to contrast; or

11. Enrolled in concurrent clinical study.

- Angiographic Exclusion

1. Target vessel:

1. shows evidence of previous dissection or perforation, or

2. has adjacent acute thrombus;

2. Lesion is highly calcified;

3. Lesion requires use of any atherectomy device during the procedure;

4. Has a pre-existing target artery aneurysm or perforation or dissection of the
target artery prior to initiation of the interventional procedure.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Peripheral Arterial Disease

Intervention(s)

Device: CorPath 200 System

Primary Outcome(s)

Device Technical Success [Time Frame: Procedure]

Adverse Events [Time Frame: Procedure]

Secondary Outcome(s)

Contrast Volume [Time Frame: Procedure]

Fluoroscopy Time [Time Frame: Procedure]

Total Procedure Time [Time Frame: Procedure]

Clinical Procedural Success [Time Frame: 24-hours]

Interventional Procedure Time [Time Frame: Procedure]

Secondary ID(s)

2014-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 19/03/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02371785