Trial Outcomes & Findings for Tissue Removal Assessment With Ultrasound of THe SFA and Popliteal (NCT NCT01938391)

NCT ID: NCT01938391

Last Updated: 2023-07-18

Results Overview

A Kaplan-Meier analysis was performed to determine the percent probability that a study participant had a TLR at 6 months and at 12 months.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 25 participants
• Primary outcome timeframe: 6 months and 12 months
• Results posted on: 2023-07-18

Participant Flow

Participant milestones

Measure	Stealth 360°® OAS Cardiovascular Systems Inc.'s Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA) Stealth 360°® OAS: Cardiovascular Systems Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)
Baseline STARTED	25
Baseline COMPLETED	25
Baseline NOT COMPLETED	0
2 Week Follow up STARTED	25
2 Week Follow up COMPLETED	25
2 Week Follow up NOT COMPLETED	0
6 Month Follow up STARTED	25
6 Month Follow up COMPLETED	24
6 Month Follow up NOT COMPLETED	1
12 Month Follow up STARTED	24
12 Month Follow up COMPLETED	22
12 Month Follow up NOT COMPLETED	2

Reasons for withdrawal

Measure	Stealth 360°® OAS Cardiovascular Systems Inc.'s Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA) Stealth 360°® OAS: Cardiovascular Systems Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)
6 Month Follow up Withdrawal by Subject	1
12 Month Follow up Physician Decision	1
12 Month Follow up Withdrawal by Subject	1

Baseline Characteristics

Tissue Removal Assessment With Ultrasound of THe SFA and Popliteal

Baseline characteristics by cohort

Measure	Stealth 360°® OAS n=25 Participants Cardiovascular Systems Inc.'s Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA) Stealth 360°® OAS: Cardiovascular Systems Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)
Age, Continuous	70.4 years STANDARD_DEVIATION 7.8 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 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	1 Participants n=5 Participants
Race (NIH/OMB) White	24 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	25 Participants n=5 Participants
Number of treated lesions	29 lesions n=5 Participants

PRIMARY outcome

Timeframe: 6 months and 12 months

A Kaplan-Meier analysis was performed to determine the percent probability that a study participant had a TLR at 6 months and at 12 months.

Outcome measures

Measure	Stealth 360°® OAS n=25 Participants Cardiovascular Systems Inc.'s Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA) Stealth 360°® OAS: Cardiovascular Systems Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)
Rate of Clinically Driven Target Lesion Revascularization (TLR) TLR at 6 months	4.0 % probablity of clinically driven TLR Interval -3.7 to 11.7
Rate of Clinically Driven Target Lesion Revascularization (TLR) TLR at 12 months	8.2 % probablity of clinically driven TLR Interval -2.7 to 19.0

PRIMARY outcome

Timeframe: Index Procedure

Mean maximum balloon inflation pressure of balloons used pre-stent placement.

Outcome measures

Measure	Stealth 360°® OAS n=31 balloons Cardiovascular Systems Inc.'s Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA) Stealth 360°® OAS: Cardiovascular Systems Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)
Mean Maximum Balloon Inflation Pressure	5.2 atm Standard Deviation 1.2

PRIMARY outcome

Timeframe: Index Procedure

Percent of study participants with an Investigator reported procedural angiographic complication (flow limiting dissection, perforation, slow flow/no flow, distal embolization and recoil).

Outcome measures

Measure	Stealth 360°® OAS n=25 Participants Cardiovascular Systems Inc.'s Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA) Stealth 360°® OAS: Cardiovascular Systems Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)
Rate of Procedural Angiographic Complications Recoil	0 Participants
Rate of Procedural Angiographic Complications Flow limiting dissections (type D-F)	0 Participants
Rate of Procedural Angiographic Complications Perforations	0 Participants
Rate of Procedural Angiographic Complications Slow flow/no reflow	0 Participants
Rate of Procedural Angiographic Complications Distal embolization	4 Participants

PRIMARY outcome

Timeframe: Baseline, 2 weeks, 6 months and 12 months

Population: At the time of this analysis 3 of the subjects did not have their ABI measured at baseline, 1 participant did not have their ABI measured at 2 weeks, 1 participant did not have their ABI measured at 6 months and 1 participant did not have their ABI measured at 12 months.

The ankle-brachial index (ABI) is the ratio of the systolic blood pressure (SBP) measured at the ankle to that measured at the brachial (upper arm) artery. Normal range of ABI is 0.9 - 1.2. Values less than 0.9 suggests presence of peripheral artery disease (PAD). Values greater than 1.2 suggests of non-compressible vessel.

Outcome measures

Measure	Stealth 360°® OAS n=25 Participants Cardiovascular Systems Inc.'s Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA) Stealth 360°® OAS: Cardiovascular Systems Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)
Ankle-Brachial Index (ABI) Measurments ABI at Baseline	0.74 ratio Standard Deviation 0.13
Ankle-Brachial Index (ABI) Measurments ABI at 2 weeks	1.01 ratio Standard Deviation 0.10
Ankle-Brachial Index (ABI) Measurments ABI at 6 months	0.96 ratio Standard Deviation 0.18
Ankle-Brachial Index (ABI) Measurments ABI at 12 months	0.95 ratio Standard Deviation 0.15

PRIMARY outcome

Timeframe: Baseline, 2 weeks, 6 month and 12 month

Population: At the time of analysis for the 6 month visit 1 participant missed their follow up visit. At the time of analysis for the 12 month visit, 22 participants completed the 12 month follow up visit.

Rutherford Classification (RC) is a commonly used clinical grading system for describing peripheral arterial disease (PAD) on a scale of 0 to 6. RC 6 is the most severe form of PAD. The RC is assessed for each participant at baseline and at each follow-up visit.

RC classification is as follows:

RC 0: Asymptomatic, no hemodynamically significant occlusive disease RC 1-3: Mild to Severe Claudication, limitation with ordinary physical activities, patient is comfortable at rest RC 4-5: Ischemic rest pain, minor tissue loss, non healing ulcer, focal gangrene RC 6: Major tissue loss, functional foot no longer salvageable

Outcome measures

Measure	Stealth 360°® OAS n=25 Participants Cardiovascular Systems Inc.'s Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA) Stealth 360°® OAS: Cardiovascular Systems Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)
Rutherford Classification (RC) RC 0 at baseline	0 Participants
Rutherford Classification (RC) RC 0 at 2 weeks	24 Participants
Rutherford Classification (RC) RC 0 at 6 month	19 Participants
Rutherford Classification (RC) RC 0 at 12 month	13 Participants
Rutherford Classification (RC) RC 1 at baseline	0 Participants
Rutherford Classification (RC) RC 1 at 2 weeks	1 Participants
Rutherford Classification (RC) RC 1 at 6 month	2 Participants
Rutherford Classification (RC) RC 1 at 12 months	8 Participants
Rutherford Classification (RC) RC 2 at baseline	0 Participants
Rutherford Classification (RC) RC 2 at 2 weeks	0 Participants
Rutherford Classification (RC) RC 2 at 6 month	0 Participants
Rutherford Classification (RC) RC 2 at 12 months	1 Participants
Rutherford Classification (RC) RC 3 at baseline	25 Participants
Rutherford Classification (RC) RC 3 at 2 weeks	0 Participants
Rutherford Classification (RC) RC 3 at 6 month	3 Participants
Rutherford Classification (RC) RC 3 at 12 months	0 Participants

PRIMARY outcome

Timeframe: Index Procedure

Population: Number of stents placed is based on number of lesions treated in the total subject population of 25. The total number of lesions treated were 29 and of those 29 lesions, 17 had a stent placed.

Number of lesions with a stent placed during the index procedure.

Outcome measures

Measure	Stealth 360°® OAS n=29 Lesions Cardiovascular Systems Inc.'s Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA) Stealth 360°® OAS: Cardiovascular Systems Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)
Stent Usage at the Time of the Index Procedure	17 Lesions

PRIMARY outcome

Timeframe: Index Procedure (pre-procedure, post-OAS treatment and post-balloon treatment)

Population: At the time of analysis 24 of 29 lesions in 25 participants could be assess by the IVUS Core Lab.

Percentage (%) of area stenosis as assessed by the intravascular ultrasound (IVUS) Core Lab. Percentage of area stenosis was calculated as 1 - (minimum lumen area / reference lumen area).

Outcome measures

Measure	Stealth 360°® OAS n=24 lesions Cardiovascular Systems Inc.'s Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA) Stealth 360°® OAS: Cardiovascular Systems Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)
Percent (%) Area Stenosis Pre-procedure, Area Stenosis (%)	76.9 percent area stenosis Interval 61.3 to 80.5
Percent (%) Area Stenosis Post-OAS treatment, Area Stenosis (%)	63.8 percent area stenosis Interval 57.6 to 76.7
Percent (%) Area Stenosis Post-Balloon treatment, Area Stenosis (%)	43.0 percent area stenosis Interval 27.3 to 56.4

Adverse Events

Stealth 360°® OAS

Serious events: 10 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	Stealth 360°® OAS n=25 participants at risk Cardiovascular Systems Inc.'s Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA) Stealth 360°® OAS: Cardiovascular Systems Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)
Injury, poisoning and procedural complications Bleeding, access site	4.0% 1/25 • Number of events 1 • AEs were collected during the index-procedure through 12 months of follow up.
Injury, poisoning and procedural complications Distal Embolization	16.0% 4/25 • Number of events 4 • AEs were collected during the index-procedure through 12 months of follow up.
Injury, poisoning and procedural complications Dissection	8.0% 2/25 • Number of events 2 • AEs were collected during the index-procedure through 12 months of follow up.
Cardiac disorders Chest Pain	4.0% 1/25 • Number of events 1 • AEs were collected during the index-procedure through 12 months of follow up.
Vascular disorders Worsening of PAD	8.0% 2/25 • Number of events 2 • AEs were collected during the index-procedure through 12 months of follow up.

Other adverse events

Measure	Stealth 360°® OAS n=25 participants at risk Cardiovascular Systems Inc.'s Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA) Stealth 360°® OAS: Cardiovascular Systems Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)
Injury, poisoning and procedural complications Dissection	40.0% 10/25 • Number of events 10 • AEs were collected during the index-procedure through 12 months of follow up.
Vascular disorders Worsening of PAD	4.0% 1/25 • Number of events 1 • AEs were collected during the index-procedure through 12 months of follow up.

Additional Information

Anvar Babaev, MD, PHD, FACC, FSCAI

NYU Langone Medical Center

Phone: 212-263-5656

Email: anvar.babaev@nyumc.org

Results disclosure agreements

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

Restriction type: LTE60