Trial Outcomes & Findings for Evaluation of the FreedomFlow™ Orbital Atherectomy System to Treat Peripheral Artery Disease (NCT NCT03635190)

NCT ID: NCT03635190

Last Updated: 2022-11-04

Results Overview

Defined as the ability of the Cardio Flow FreedomFlow™ Orbital Circumferential Atherectomy System to achieve a residual diameter stenosis ≤50% without adjunctive therapy.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 112 participants
• Primary outcome timeframe: At the time of the index procedure, usually within one hour after starting the procedure
• Results posted on: 2022-11-04

Participant Flow

Unit of analysis: Lesions

Participant milestones

Measure	Atherectomy Treatment Per Lesion Measure outcomes of atherectomy treatment based on all lesions treated in 112 patients.
Overall Study STARTED	112 154
Overall Study COMPLETED	103 152
Overall Study NOT COMPLETED	9 2

Reasons for withdrawal

Measure	Atherectomy Treatment Per Lesion Measure outcomes of atherectomy treatment based on all lesions treated in 112 patients.
Overall Study Lost to Follow-up	4
Overall Study Death	3
Overall Study Withdrawal by Subject	1
Overall Study Patient moved and did not return for follow up	1

Baseline Characteristics

Ethnicity not reported for 1 patient

Baseline characteristics by cohort

Measure	Interventional Treatment n=152 Lesions 112 patients had 154 lesions treated
Age, Continuous	70.1 years STANDARD_DEVIATION 9.8 • n=93 Participants
Sex: Female, Male Female	45 Participants n=93 Participants
Sex: Female, Male Male	67 Participants n=93 Participants
Race/Ethnicity, Customized Asian	1 Participants n=93 Participants • Ethnicity not reported for 1 patient
Race/Ethnicity, Customized Black or African Origin	16 Participants n=93 Participants • Ethnicity not reported for 1 patient
Race/Ethnicity, Customized Caucasian	86 Participants n=93 Participants • Ethnicity not reported for 1 patient
Race/Ethnicity, Customized Hispanic or Latino	7 Participants n=93 Participants • Ethnicity not reported for 1 patient
Race/Ethnicity, Customized Native American or Alaskan Native	1 Participants n=93 Participants • Ethnicity not reported for 1 patient
Race/Ethnicity, Customized Not Reported	1 Participants n=93 Participants • Ethnicity not reported for 1 patient
Region of Enrollment United States	112 participants n=93 Participants
Rutherford Classification 2 Moderate Claudication	9 Participants n=93 Participants
Rutherford Classification 3 Severe Claudication	55 Participants n=93 Participants
Rutherford Classification 4 Ischemic Rest Pain	34 Participants n=93 Participants
Rutherford Classification 5 Minor Tissue Loss	14 Participants n=93 Participants

PRIMARY outcome

Timeframe: At the time of the index procedure, usually within one hour after starting the procedure

Population: 154 distinct lesions in 112 patients were analyzed

Defined as the ability of the Cardio Flow FreedomFlow™ Orbital Circumferential Atherectomy System to achieve a residual diameter stenosis ≤50% without adjunctive therapy.

Outcome measures

Measure	Site Reported Treatment n=154 lesion Atherectomy treated lesions Remove atherosclerotic plaque and modify vessel wall compliance within peripheral arterial vessels.	Primary Assisted Patency Patency will be evaluated by duplex ultrasound and evaluated by an independent Vascular Ultrasound Core Laboratory. The restenosis is defined as PSVR of 2.5.
Technical Success	144 lesion	—

PRIMARY outcome

Timeframe: 30 days

Primary safety endpoint is freedom from a composite of new onset major adverse events (MAE) at 30-day follow-up as adjudicated by an Independent Clinical Events Committee. This endpoint is evaluated on a per patient basis.

Outcome measures

Measure	Site Reported Treatment n=112 Participants Atherectomy treated lesions Remove atherosclerotic plaque and modify vessel wall compliance within peripheral arterial vessels.	Primary Assisted Patency Patency will be evaluated by duplex ultrasound and evaluated by an independent Vascular Ultrasound Core Laboratory. The restenosis is defined as PSVR of 2.5.
Freedom From Major Adverse Events	104 Participants	—

SECONDARY outcome

Timeframe: At index procedure

Defined as the ability of the FreedomFlow™ Orbital Circumferential Atherectomy System to achieve a final diameter stenosis <50% immediately post treatment with or without adjunctive therapy, as assessed by an independent Angiographic Core Laboratory.

Outcome measures

Measure	Site Reported Treatment n=144 lesion Atherectomy treated lesions Remove atherosclerotic plaque and modify vessel wall compliance within peripheral arterial vessels.	Primary Assisted Patency Patency will be evaluated by duplex ultrasound and evaluated by an independent Vascular Ultrasound Core Laboratory. The restenosis is defined as PSVR of 2.5.
Clinical Success	143 lesions	—

SECONDARY outcome

Timeframe: At index procedure

Defined as <50% residual stenosis at target lesion with or without adjunctive therapy, no procedure-related MAE, no device malfunction causing the procedure to be aborted.

Outcome measures

Measure	Site Reported Treatment n=112 Participants Atherectomy treated lesions Remove atherosclerotic plaque and modify vessel wall compliance within peripheral arterial vessels.	Primary Assisted Patency Patency will be evaluated by duplex ultrasound and evaluated by an independent Vascular Ultrasound Core Laboratory. The restenosis is defined as PSVR of 2.5.
Procedure Success	102 Participants	—

SECONDARY outcome

Timeframe: 30 days and 6 months

Population: Only 107 patients had ABI reported at 30 days and 103 patients had ABI reported at 6 months

ABI measured at baseline, 30 days and 6 months. ABI ranges from 0 to 1, with smaller values indicating more severe disease. Normal ABI is 1.

Outcome measures

Measure	Site Reported Treatment n=112 Participants Atherectomy treated lesions Remove atherosclerotic plaque and modify vessel wall compliance within peripheral arterial vessels.	Primary Assisted Patency Patency will be evaluated by duplex ultrasound and evaluated by an independent Vascular Ultrasound Core Laboratory. The restenosis is defined as PSVR of 2.5.
Ankle Brachia, Index (ABI) Measured at Baseline, 30 Days and 6 Months Baseline ABI	0.69 units on a scale Standard Deviation 0.22	—
Ankle Brachia, Index (ABI) Measured at Baseline, 30 Days and 6 Months 30 day ABI	0.90 units on a scale Standard Deviation 0.25	—
Ankle Brachia, Index (ABI) Measured at Baseline, 30 Days and 6 Months 6 month ABI	0.85 units on a scale Standard Deviation 0.29	—

SECONDARY outcome

Timeframe: 30 days and 6 months

Population: Only 107 Patients had reported Rutherford Class at 30 days and only 103 Patients had reported Rutherford Class at 6 months

Change in Rutherford Classification at 30 days and 6 months. Rutherford scale ranges from 0 to 6 with higher values indicating more severe disease. Rutherford classifications are: 0 Asymptomatic; 1 Mild Claudication; 2 Moderate Claudication; 3 Severe Claudication; 4 Ischemic Rest Pain; 5 Minor Tissue Loss; 6 Major Tissue Loss.

Outcome measures

Measure	Site Reported Treatment n=112 Participants Atherectomy treated lesions Remove atherosclerotic plaque and modify vessel wall compliance within peripheral arterial vessels.	Primary Assisted Patency Patency will be evaluated by duplex ultrasound and evaluated by an independent Vascular Ultrasound Core Laboratory. The restenosis is defined as PSVR of 2.5.
Rutherford Classification Baseline	3.50 units on a scale Standard Deviation 0.82	—
Rutherford Classification 30 Days	1.00 units on a scale Standard Deviation 1.32	—
Rutherford Classification 6 Months	0.90 units on a scale Standard Deviation 1.29	—

SECONDARY outcome

Timeframe: Baseline, 30 days and 6 months

Population: Only 107 patients had reported VascuQoL at 30 days and only 103 patients had reported VascuQoL at 6 months

Patient reported outcomes (PRO, VascuQoL questionnaire) at baseline, 30 days and 6 months. The VascuQoL questionnaire is a validated PRO for lower limb ischemia patients. The range of scores is 1 (worst) to 7 (best)

Outcome measures

Measure	Site Reported Treatment n=112 Participants Atherectomy treated lesions Remove atherosclerotic plaque and modify vessel wall compliance within peripheral arterial vessels.	Primary Assisted Patency Patency will be evaluated by duplex ultrasound and evaluated by an independent Vascular Ultrasound Core Laboratory. The restenosis is defined as PSVR of 2.5.
Vascular Quality of Life Questionnaire (VascuQoL) Administered at Baseline, 30 Days and 6 Months Baseline VascuQoL	3.96 units on a scale Standard Deviation 1.42	—
Vascular Quality of Life Questionnaire (VascuQoL) Administered at Baseline, 30 Days and 6 Months 30 day VascuQoL	5.33 units on a scale Standard Deviation 1.27	—
Vascular Quality of Life Questionnaire (VascuQoL) Administered at Baseline, 30 Days and 6 Months 6 month VascuQoL	5.32 units on a scale Standard Deviation 1.30	—

SECONDARY outcome

Timeframe: 30 days and 6 months

Population: Onlt 103 patients had TLR reported at 6 months

Clinically driven target lesion revascularization (TLR) at 6 months, target vessel revascularization (TVR) at 30 days and 6 months (as assessed by an independent Angiographic Core Laboratory). Clinically driven target lesion revascularization refers to disease progression that is caused by a recurrence of stenosis at the lesion that was treated; target vessel revascularization refers to disease progression that is caused by a recurrence of stenosis in the same vessel as the treated lesion but at a different site.

Outcome measures

Measure	Site Reported Treatment n=112 Participants Atherectomy treated lesions Remove atherosclerotic plaque and modify vessel wall compliance within peripheral arterial vessels.	Primary Assisted Patency Patency will be evaluated by duplex ultrasound and evaluated by an independent Vascular Ultrasound Core Laboratory. The restenosis is defined as PSVR of 2.5.
Target Lesion and Vessel Revascularization Freedon From TLR at 30 days	112 Participants	—
Target Lesion and Vessel Revascularization Freedom from TLR at 6 months	103 Participants	—

SECONDARY outcome

Timeframe: 30 days and 6 months

Population: Only 129 lesions had patency reported at 30 days and only 121 lesions had patency reported at 6 months

Primary patency, primary assisted patency and secondary patency at 30 days and 6 months. Patency will be evaluated on a per lesion basis by duplex ultrasound and evaluated by an independent Vascular Ultrasound Core Laboratory. Restenosis is defined as Peak Systolic Velocity Rate (PSVR) of 2.5. Patency is determined using ultrasound to measure velocity. Patency is indicated for PSVR values < 2.5

Outcome measures

Measure	Site Reported Treatment n=129 lesion Atherectomy treated lesions Remove atherosclerotic plaque and modify vessel wall compliance within peripheral arterial vessels.	Primary Assisted Patency n=129 lesion Patency will be evaluated by duplex ultrasound and evaluated by an independent Vascular Ultrasound Core Laboratory. The restenosis is defined as PSVR of 2.5.
Vessel Patency Primary Patency at 30 days	123 lesion	128 lesion
Vessel Patency Primary Patency at 6 months	86 lesion	113 lesion

Adverse Events

Interventional

Serious events: 32 serious events

Other events: 71 other events

Deaths: 3 deaths

Serious adverse events

Measure	Interventional n=112 participants at risk Atherectomy Treatment
Blood and lymphatic system disorders Anemia	4.5% 5/112 • Number of events 5 • 6 months
Infections and infestations Infection, local	3.6% 4/112 • Number of events 5 • 6 months
Vascular disorders Target Lesion Revascularization	3.6% 4/112 • Number of events 4 • 6 months
Vascular disorders Distal Embolization	2.7% 3/112 • Number of events 3 • 6 months
Surgical and medical procedures Amputation below the knee	1.8% 2/112 • Number of events 3 • 6 months
Cardiac disorders Congestive Heart Failure	1.8% 2/112 • Number of events 2 • 6 months
Infections and infestations Infection, systemic	1.8% 2/112 • Number of events 2 • 6 months
Vascular disorders Non-Target Vessel Revascularization	1.8% 2/112 • Number of events 2 • 6 months
Vascular disorders Target Vessel Revascularization	0.89% 1/112 • Number of events 2 • 6 months
Vascular disorders Access Site Hematoma > 6cm	0.89% 1/112 • Number of events 1 • 6 months
Cardiac disorders Atrial Fibrillation	0.89% 1/112 • Number of events 1 • 6 months
Cardiac disorders Ventricular Tachycardia	0.89% 1/112 • Number of events 1 • 6 months
Vascular disorders Hypertension	0.89% 1/112 • Number of events 1 • 6 months
Cardiac disorders Myocardial Infarction	0.89% 1/112 • Number of events 1 • 6 months
General disorders Pain	0.89% 1/112 • Number of events 1 • 6 months
Renal and urinary disorders Renal Insufficiency	0.89% 1/112 • Number of events 1 • 6 months
Vascular disorders Target Vessel Non-target Lesion Revascularization	0.89% 1/112 • Number of events 1 • 6 months
Vascular disorders Vessel Slow Flow Phenomenon	0.89% 1/112 • Number of events 1 • 6 months
Vascular disorders Vessel Perforation Type I	0.89% 1/112 • Number of events 1 • 6 months
General disorders Other	14.3% 16/112 • Number of events 23 • 6 months

Other adverse events

Measure	Interventional n=112 participants at risk Atherectomy Treatment
Vascular disorders Other	63.4% 71/112 • Number of events 199 • 6 months

Additional Information

Michael J Kallok, PhD

Cardio Flow, Inc.

Phone: 16512531754

Email: mjkallok@cardioflow.net

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place