Clinical trial NCT02371785: Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease
Official title: Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Peripheral Arterial Disease
Critical Limb Ischemia
Claudication
Percutaneous Vascular Intervention
Peripheral Vascular Intervention
Lead sponsor: Corindus Inc.
Sponsor class: INDUSTRY
First posted: 2015-02-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: The CorPath 200 System is currently marketed for remotely delivering guide wires, balloons and stents to blockages in the coronary arteries. This study will evaluate the feasibility of CorPath 200 System to deliver guide wires and balloons to blockages in non-coronary arteries.

Guide wires and balloons are delivered to blockages in the lower limbs manually by doctors.If this study shows that guide wires and balloons can be safely delivered to blockages in the lower limbs, then it will be an alternative for physicians.

Eligibility 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.

Primary outcomes:
measure: Device Technical Success
timeFrame: Procedure
measure: Adverse Events
timeFrame: Procedure
Secondary outcomes:
measure: Clinical Procedural Success
timeFrame: 24-hours
measure: Fluoroscopy Time
timeFrame: Procedure
measure: Contrast Volume
timeFrame: Procedure
measure: Total Procedure Time
timeFrame: Procedure
measure: Interventional Procedure Time
timeFrame: Procedure
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medizinische Univeristät Graz
Study officials:
affiliation: Medizinische Universität Graz
name: Marianne Brodmann, M.D.
role: PRINCIPAL_INVESTIGATOR
References: