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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02126540




Registration number
NCT02126540
Ethics application status
Date submitted
28/04/2014
Date registered
30/04/2014
Date last updated
16/12/2015

Titles & IDs
Public title
Trial of Pantheris System, an Atherectomy Device That Provides Imaging While Removing Plaque in Lower Extremity Arteries
Scientific title
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
Secondary ID [1] 0 0
P0638
Universal Trial Number (UTN)
Trial acronym
COMBINE-II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Pantheris Atherectomy System

Experimental: Primary Cohort - Main cohort; treatment Arm with Pantheris Atherectomy System


Treatment: Devices: Pantheris Atherectomy System
Treatment device in primary cohort arm; OCT image guided directional atherectomy

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Day 0 through Day 30
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Day 0
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Day 0
Secondary outcome [2] 0 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.
Timepoint [2] 0 0
Day 0
Secondary outcome [3] 0 0
Secondary Effectiveness Endpoint - Ankle-Brachial Index at 30 days
Timepoint [3] 0 0
Day 30
Secondary outcome [4] 0 0
Secondary Effectiveness Endpoint - Rutherford Classification at 30 days.
Timepoint [4] 0 0
Day 30

Eligibility
Key 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. -
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Avinger, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02126540
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andreq Holden, MD
Address 0 0
Auckland City Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02126540