Trial of Pantheris System, an Atherectomy Device That Provides Imaging While Removing Plaque in Lower Extremity Arteries (COMBINE-II)

A Non-randomized, Multi-center Feasibility Trial of the Avinger Pantheris System, an Atherectomy Device That Provides Directional Visualization and Imaging While Removing Plaque in Diseased Lower Extremity Arteries

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.

Study Overview

• Status: Withdrawn
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: Pantheris Atherectomy System

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• New Zealand
  • Auckland, New Zealand, 1023
    • Auckland City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≥ 18 years old.
2. Patient is a candidate for percutaneous intervention for peripheral vascular disease in the legs.
3. Patient is willing and able to give informed consent
4. Documented symptomatic atherosclerotic peripheral vascular disease Rutherford Classification 2-5.
5. Reference vessel lumen proximal to target lesion >3.0 mm in diameter by visual estimation.
6. 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.
7. 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.
8. Patient is capable of meeting requirements and be present at the follow-up clinic visits at 30 days.
9. At least one patent tibial run-off vessel at baseline. -

Exclusion Criteria:

1. Subject is pregnant or breast feeding.
2. Rutherford Class 0 to 1 (asymptomatic and mild claudication).
3. Rutherford Class 6 (critical limb ischemia).
4. Severe calcification of the target lesion.
5. Target lesion with any type of stent or graft.
6. Target lesion in the iliac artery.
7. Target lesion stenosis <70%.
8. 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.
9. Endovascular or surgical procedure performed on the index limb less than or equal to 30 days prior to the index procedure.
10. Planned endovascular or surgical procedure 30 days after the index procedure.
11. Lesion in the contralateral limb requiring intervention during the index procedure or within 30 days of the index procedure.
12. Subjects with active infections whether they are being currently treated or not.
13. Hemodialysis or GFR <30 mL/min or creatinine level >2.5mg/dL.
14. Evidence or history of intracranial or gastrointestinal bleeding, intracranial aneurysm, myocardial infarction or stroke within the past 2 months.
15. Evidence or history of aneurysmal target vessel within the past 2 months.
16. History of severe trauma, fracture, major surgery or biopsy of a parenchymal organ within the past 14 days.
17. Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
18. Subjects in whom anti-platelet, anticoagulant, or thrombolytic therapy is contraindicated.
19. History of heparin-induced thrombocytopenia (HIT).
20. Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 125,000/mm2 , known coagulopathy, or INR >1.5.
21. Any thrombolytic therapy within 2 weeks of the index procedure.
22. Any clinical and/or angiographic complication attributed to the use of another device prior to the insertion of the Pantheris into the subject.
23. Subjects or their legal guardians who have not or will not sign the Informed Consent.
24. Subjects who are unwilling or unable to comply with the follow-up study requirements.
25. Participation in any study of an investigational device, medication, biologic or other agent within 30 days prior to enrollment that is either a cardiovascular study or could, in the judgment of the investigator, affect the results of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Primary Cohort; Main cohort; treatment Arm with Pantheris Atherectomy System	Device: Pantheris Atherectomy System; Treatment device in primary cohort arm; OCT image guided directional atherectomy; Other Names: Pantheris

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 PerforationsClinically Significant DissectionsClinically Significant EmbolusPseudoaneurysm	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Safety Endpoint	Freedom from procedural emboli, defined as a new occlusion of any visualized runoff vessel which cannot be reversed with an intravascular vasodilator.	Day 0
Secondary Effectiveness Endpoint	Procedural success defined as the percent of target lesions that have residual diameter stenosis < 30% post-Pantheris and any other adjunctive therapy.	Day 0
Secondary Effectiveness Endpoint	Ankle-Brachial Index at 30 days	Day 30
Secondary Effectiveness Endpoint	Rutherford Classification at 30 days.	Day 30

Collaborators and Investigators

• Sponsor: Avinger, Inc.
• Investigators: Principal Investigator: Andreq Holden, MD, Auckland City Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): January 1, 2016
• Study Completion (Anticipated): July 1, 2016

Study Registration Dates

• First Submitted: April 28, 2014
• First Submitted That Met QC Criteria: April 29, 2014
• First Posted (Estimate): April 30, 2014

Study Record Updates

• Last Update Posted (Estimate): December 16, 2015
• Last Update Submitted That Met QC Criteria: December 15, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Optical Coherence Tomography; Peripheral Arterial Disease; Atherectomy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: P0638