Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02126540
Other study ID # P0638
Secondary ID
Status Withdrawn
Phase N/A
First received April 28, 2014
Last updated December 15, 2015
Start date September 2015
Est. completion date July 2016

Study information

Verified date December 2015
Source Avinger, Inc.
Contact n/a
Is FDA regulated No
Health authority New Zealand: Ethics CommitteeNew Zealand: Health and Disability Ethics Committees
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date July 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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

Locations

Country Name City State
New Zealand Auckland City Hospital Auckland

Sponsors (1)

Lead Sponsor Collaborator
Avinger, Inc.

Country where clinical trial is conducted

New Zealand, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Primary 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 No
Secondary 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 Yes
Secondary 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 No
Secondary Secondary Effectiveness Endpoint Ankle-Brachial Index at 30 days Day 30 No
Secondary Secondary Effectiveness Endpoint Rutherford Classification at 30 days. Day 30 No
See also
  Status Clinical Trial Phase
Recruiting NCT06032065 - Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD) Phase 3
Active, not recruiting NCT03987061 - MOTIV Bioresorbable Scaffold in BTK Artery Disease N/A
Recruiting NCT03506633 - Impacts of Mitochondrial-targeted Antioxidant on Peripheral Artery Disease Patients N/A
Active, not recruiting NCT03506646 - Dietary Nitrate Supplementation and Thermoregulation N/A
Active, not recruiting NCT04677725 - NEtwork to Control ATherothrombosis (NEAT Registry)
Recruiting NCT05961943 - RESPONSE-2-PAD to Reduce Sedentary Time in Peripheral Arterial Disease Patients N/A
Recruiting NCT06047002 - Personalised Antiplatelet Therapy for Patients With Symptomatic Peripheral Arterial Disease
Completed NCT03185052 - Feasibility of Outpatient Care After Manual Compression in Patients Treated for Peripheral Arterial Disease by Endovascular Technique With 5F Sheath Femoral Approach N/A
Recruiting NCT05992896 - A Study of Loco-Regional Liposomal Bupivacaine Injection Phase 4
Completed NCT04635501 - AbsorbaSeal (ABS 5.6.7) Vascular Closure Device Trial N/A
Recruiting NCT04584632 - The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery N/A
Withdrawn NCT03994185 - The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease N/A
Withdrawn NCT03538392 - Serranator® Alto Post Market Clinical Follow Up (PMCF) Study
Recruiting NCT02915796 - Autologous CD133(+) Cells as an Adjuvant to Below the Knee Percutaneous Transluminal Angioplasty Phase 1
Active, not recruiting NCT02900924 - Observational Study to Evaluate the BioMimics 3D Stent System: MIMICS-3D
Completed NCT02901847 - To Evaluate the Introduction of a Public Health Approach to Peripheral Arterial Disease (PAD) Using National Centre for Sport and Exercise Medicine Facilities. N/A
Not yet recruiting NCT02455726 - Magnesium Oral Supplementation to Reduce Pain Inpatients With Severe Peripheral Arterial Occlusive Disease N/A
Not yet recruiting NCT02387450 - Reduced Cardiovascular Morbi-mortality by Sildenafil in Patients With Arterial Claudication Phase 2/Phase 3
Completed NCT02022423 - Physical Activity Daily - An Internet-Based Walking Program for Patients With Peripheral Arterial Disease N/A
Completed NCT02384980 - Saving Life and Limb: FES for the Elderly With PAD Phase 1