Peripheral Arterial Disease
Conditions
Keywords
Peripheral Artery Disease, Atherectomy, Orbital Atherectomy
Brief summary
This trial is a First in Human early feasibility study of a novel atherectomy device to treat peripheral artery disease. The trial is a prospective, single arm design that will enroll 10 patients at 1 - 2 sites. Patients will be followed at 30 days and 6 months to evaluate vessel patency following treatment. Safety will be assessed by monitoring adverse events throughout the study. Safety and Efficacy will be evaluated by comparing study results to established performance criteria,
Detailed description
Feasibility Clinical Trial of the Cardio Flow FreedomFlow™ Orbital Atherectomy System to Treat Peripheral Artery Disease (FAST Trial) is a prospective non-randomized single arm study that will enroll up to 10 patients at 1 - 2 sites. The study will evaluate the safety and effectiveness of the Cardio Flow atherectomy device for plaque removal in de novo target lesions in the peripheral vasculature of the lower extremities. The primary safety endpoint is defined as freedom from a composite of new onset major adverse events through the 30-day follow-up as adjudicated by an independent Clinical Events physician. The primary effectiveness endpoint is defined as the ability of the Cardio Flow Device to achieve a residual diameter stenosis ≤ 50% without adjunctive therapy, determined by Angiographic core lab evaluation.
Interventions
DEVICECardio Flow FreedomFlow™ Orbital Atherectomy System treatment
Occlusive lesions will be treated using atherectomy with or without adjunctive low pressure balloon angioplasty.
DEVICEBalloon Angioplasty
Low pressure balloon angioplasty may be used following atherectomy
Sponsors
Libra Medical
Cardio Flow, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Candidate for percutaneous endovascular intervention in the lower extremity; * Disease is located in peripheral arteries between 2mm and 5mm diameter; * Ankle brachial index ≤ 0.90; * Rutherford classification 2,3,4 or 5; * De novo target lesion has ≥ 50% stenosis; * Target lesion length ≤ 200 cm; * At least 1 patent tibial vessel runoff; * Written, signed informed consent.
Exclusion criteria
* Female not using adequate contraception or is breastfeeding; * Rutherford class 0 1, and 6; * target lesion within a native graft, * in-stent restenosis, * ≤ 50% occlusion, or chronic total occlusion; * history of vascular surgery or interventional procedure on index limb within 30 days prior to procedure, or planned procedure within 30 days after index procedure, lesion in contralateral limb requiring intervention during index procedure or within 30 days of index procedure; * known or suspected systemic infection; * unstable coronary disease; significant kidney disease requiring dialysis; * evidence of aneurysmal target vessel within past 2 months; * evidence of intracranial or GI bleeding, intracranial aneurysm, MI or stroke within 2 months of baseline evaluation; * history of heparin-induced thrombocytopenia; * contraindication to anti-platelet, anticoagulant, or thrombolytic therapy; * uncorrected bleeding disorders; * thrombolytic therapy within 2 weeks of index procedure; * life expectancy less than 12 months; * unwilling or unable to comply with follow-up requirements; * intraoperative complications due to the use of a marketed device prior to use of the atherectomy system; * currently participating in an investigational drug or other device study that has not completed primary endpoint; * unable to tolerate standard interventional procedures if the study device is not effective.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Treated Lesions With Achievement of ≤ 50% Residual Stenosis Without Adjunctive Therapy | At time of procedure | Achievement of ≤ 50% residual stenosis without adjunctive therapy as assessed angiographically on a per lesion basis |
| Number of Participants Who Were Free From New-onset Major Adverse Events at 30 Days Post-treatment | 30 days | Major adverse events include the following: * All cause cardiovascular mortality. * Myocardial infarction (MI): Any newly diagnosed MI post procedure, defined as CK-MB ≥2X upper limit normal (ULN). * Clinically driven target lesion revascularization (TLR): any repeat percutaneous or surgical intervention to treat objectively documented symptoms of recurrent ischemia attributable to the treated lesion. * Clinically significant target vessel dissection: NHLBI grade C or greater as confirmed by angiography. * Clinically significant target vessel perforation: NHLBI Type III as confirmed by angiography. * Unplanned major target limb amputation: Amputation at the level of the trans-metatarsals or higher that was not previously planned * Clinically relevant distal embolization: Emboli requiring surgical or medical intervention and/or the presence of symptoms. * Pseudoaneurysm: disruption of the arterial wall at the treatment site as confirmed by angiography. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Events | Through six months | All device and procedure related Serious Adverse Events at 30 days and 6 months |
| Number of Lesions With Achievement of ≤ 50% Residual Stenosis With or Without Adjunctive Low-pressure Balloon Therapy | At time of procedure | Ability to achieve \<50% residual diameter stenosis with or without adjunctive low-pressure balloon therapy on a per-lesion basis. Operator can follow atherectomy treatment with adjunctive balloon therapy. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group Patients with occlusive arterial disease who meet the study criteria and provide informed consent will receive atherectomy treatment with the investigational device.
Cardio Flow FreedomFlow™ Orbital Atherectomy System treatment: Occlusive lesions will be treated using atherectomy with or without adjunctive low pressure balloon angioplasty.
Balloon Angioplasty: Low pressure balloon angioplasty may be used following atherectomy | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Treatment Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age, Continuous | 68.3 years STANDARD_DEVIATION 11.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 10 participants |
| Rutherford Classification | 3.9 units on a scale STANDARD_DEVIATION 0.9 |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 4 / 10 |
| serious Total, serious adverse events | 4 / 10 |
Outcome results
Primary
Number of Participants Who Were Free From New-onset Major Adverse Events at 30 Days Post-treatment
Major adverse events include the following: * All cause cardiovascular mortality. * Myocardial infarction (MI): Any newly diagnosed MI post procedure, defined as CK-MB ≥2X upper limit normal (ULN). * Clinically driven target lesion revascularization (TLR): any repeat percutaneous or surgical intervention to treat objectively documented symptoms of recurrent ischemia attributable to the treated lesion. * Clinically significant target vessel dissection: NHLBI grade C or greater as confirmed by angiography. * Clinically significant target vessel perforation: NHLBI Type III as confirmed by angiography. * Unplanned major target limb amputation: Amputation at the level of the trans-metatarsals or higher that was not previously planned * Clinically relevant distal embolization: Emboli requiring surgical or medical intervention and/or the presence of symptoms. * Pseudoaneurysm: disruption of the arterial wall at the treatment site as confirmed by angiography.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Group | Number of Participants Who Were Free From New-onset Major Adverse Events at 30 Days Post-treatment | 10 Participants |
Primary
Number of Treated Lesions With Achievement of ≤ 50% Residual Stenosis Without Adjunctive Therapy
Achievement of ≤ 50% residual stenosis without adjunctive therapy as assessed angiographically on a per lesion basis
Time frame: At time of procedure
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Treatment Group | Number of Treated Lesions With Achievement of ≤ 50% Residual Stenosis Without Adjunctive Therapy | 3 lesion |
Secondary
Number of Lesions With Achievement of ≤ 50% Residual Stenosis With or Without Adjunctive Low-pressure Balloon Therapy
Ability to achieve \<50% residual diameter stenosis with or without adjunctive low-pressure balloon therapy on a per-lesion basis. Operator can follow atherectomy treatment with adjunctive balloon therapy.
Time frame: At time of procedure
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Treatment Group | Number of Lesions With Achievement of ≤ 50% Residual Stenosis With or Without Adjunctive Low-pressure Balloon Therapy | 11 Lesion |
Secondary
Serious Adverse Events
All device and procedure related Serious Adverse Events at 30 days and 6 months
Time frame: Through six months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Group | Serious Adverse Events | 0 Participants |