Trial of Pantheris System, an Atherectomy Device That Provides Imaging While Removing Plaque in Lower Extremity Arteries

NCT02126540 | Withdrawn DMC

• 1 other identifier: P0638
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and effectiveness of the Pantheris System to perform atherectomy while using directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque from diseased lower extremity arteries.

Conditions

Peripheral Arterial Disease

Keywords

Peripheral Arterial Disease; Atherectomy; Optical Coherence Tomography

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint

  The primary safety endpoint is defined as freedom from major adverse events (MAE) through 30 day follow-up: * Clinically driven target lesion revascularization (TLR) * Myocardial infarction (MI) * Cardiovascular related deaths * Unplanned, major index limb amputation * Device Related Events: * Clinically Significant Perforations * Clinically Significant Dissections * Clinically Significant Embolus * Pseudoaneurysm

  Day 0 through Day 30

• Primary Effectiveness Endpoint

  The primary efficacy endpoint of technical success is defined as the percent of target lesions that has a residual diameter stenosis \<50% post the Pantheris device alone as assessed by an independent review at the time of treatment using quantitative angiography or visual estimate.

  Day 0

Secondary Outcomes (4)

• Secondary Safety Endpoint

  Day 0

• Secondary Effectiveness Endpoint

  Day 0

• Secondary Effectiveness Endpoint

  Day 30

• Secondary Effectiveness Endpoint

  Day 30

Study Arms (1)

Primary Cohort

EXPERIMENTAL

Main cohort; treatment Arm with Pantheris Atherectomy System

Device: Pantheris Atherectomy System

Interventions

Pantheris Atherectomy System DEVICE

Treatment device in primary cohort arm; OCT image guided directional atherectomy

Also known as: Pantheris

Primary Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old.
• Patient is a candidate for percutaneous intervention for peripheral vascular disease in the legs.
• Patient is willing and able to give informed consent
• Documented symptomatic atherosclerotic peripheral vascular disease Rutherford Classification 2-5.
• Reference vessel lumen proximal to target lesion \>3.0 mm in diameter by visual estimation.
• Subject has de novo target lesion(s) with stenosis \>70% by visual estimation distal to the profunda femoral artery. No more than 2 lesions may be treated with the Pantheris device.
• Target lesion length \<10 cm if target lesion \>70% and \<99% stenosed. If target lesion a chronic total occlusion (99-100% stenosed), target lesion length \<4 cm.
• Patient is capable of meeting requirements and be present at the follow-up clinic visits at 30 days.
• At least one patent tibial run-off vessel at baseline. -

You may not qualify if:

• Subject is pregnant or breast feeding.
• Rutherford Class 0 to 1 (asymptomatic and mild claudication).
• Rutherford Class 6 (critical limb ischemia).
• Severe calcification of the target lesion.
• Target lesion with any type of stent or graft.
• Target lesion in the iliac artery.
• Target lesion stenosis \<70%.
• Subjects with significant (\>70%) occlusive lesions proximal to the target lesion not successfully treated during the index procedure (upstream disease) and prior to treatment of the target lesion.
• Endovascular or surgical procedure performed on the index limb less than or equal to 30 days prior to the index procedure.
• Planned endovascular or surgical procedure 30 days after the index procedure.
• Lesion in the contralateral limb requiring intervention during the index procedure or within 30 days of the index procedure.
• Subjects with active infections whether they are being currently treated or not.
• Hemodialysis or GFR \<30 mL/min or creatinine level \>2.5mg/dL.
• Evidence or history of intracranial or gastrointestinal bleeding, intracranial aneurysm, myocardial infarction or stroke within the past 2 months.
• Evidence or history of aneurysmal target vessel within the past 2 months.

Sponsors & Collaborators

• Avinger, Inc.: lead

Study Sites (1)

Auckland City Hospital

Auckland, 1023, New Zealand

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Andreq Holden, MD

  Auckland City Hospital

  PRINCIPAL INVESTIGATOR

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 28, 2014
• First Posted: April 30, 2014
• Study Start: September 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: July 1, 2016
• Last Updated: December 16, 2015

Record last verified: 2015-12

Locations

NZ (1)