Trial Outcomes & Findings for Feasibility Clinical Trial of the Cardio Flow Orbital Atherectomy System to Treat Peripheral Artery Disease (PAD) (NCT NCT03365154)

NCT ID: NCT03365154

Last Updated: 2021-05-20

Results Overview

Achievement of ≤ 50% residual stenosis without adjunctive therapy as assessed angiographically on a per lesion basis

Recruitment status

COMPLETED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

At time of procedure

Results posted on

2021-05-20

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Feasibility Clinical Trial of the Cardio Flow Orbital Atherectomy System to Treat Peripheral Artery Disease (PAD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Group n=10 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Age, Continuous	68.3 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants
Rutherford Classification	3.9 units on a scale STANDARD_DEVIATION 0.9 • n=5 Participants

PRIMARY outcome

Timeframe: At time of procedure

Achievement of ≤ 50% residual stenosis without adjunctive therapy as assessed angiographically on a per lesion basis

Outcome measures

Outcome measures
Measure	Treatment Group n=10 lesion 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
Number of Treated Lesions With Achievement of ≤ 50% Residual Stenosis Without Adjunctive Therapy	3 lesion

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment Group n=10 Participants 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
Number of Participants Who Were Free From New-onset Major Adverse Events at 30 Days Post-treatment	10 Participants

SECONDARY outcome

Timeframe: Through six months

All device and procedure related Serious Adverse Events at 30 days and 6 months

Outcome measures

Outcome measures
Measure	Treatment Group n=10 Participants 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
Serious Adverse Events	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment Group n=11 Lesion 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
Number of Lesions With Achievement of ≤ 50% Residual Stenosis With or Without Adjunctive Low-pressure Balloon Therapy	11 Lesion

Adverse Events

Treatment Group

Serious events: 4 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment Group n=10 participants at risk 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
Gastrointestinal disorders Other	10.0% 1/10 • Number of events 1 • 6 months
Infections and infestations Amputation below the knee	10.0% 1/10 • Number of events 2 • 6 months
Blood and lymphatic system disorders Bleeding complication requires transfusion	10.0% 1/10 • Number of events 1 • 6 months
Infections and infestations Other	10.0% 1/10 • Number of events 4 • 6 months

Other adverse events

Other adverse events
Measure	Treatment Group n=10 participants at risk 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
Gastrointestinal disorders Other	10.0% 1/10 • Number of events 1 • 6 months
Infections and infestations Other	10.0% 1/10 • Number of events 1 • 6 months

Additional Information

Phil Zhang, MD

Libra Medical

Phone: 6692039308

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60