TRUTH: Tissue Removal Assessment With Ultrasound of THe SFA and Popliteal

• Sponsor: Cardiovascular Systems Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01938391
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arm: 1
• Duration (Months): 25
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

IVUS imaging will be utilized to assess performance of the Sponsor's Orbital Atherectomy System (OAS) followed by adjunctive balloon angioplasty (BA) in patients who have symptomatic peripheral artery disease (PAD) occurring in the Superficial Femoral Artery (SFA), Popliteal (POP), and/or Tibioperoneal Trunk (TPT).

Condition or Disease	Intervention/Treatment	Phase
Peripheral Artery Disease; PAD; Claudication; Peripheral Vascular Disease; PVD	Device: Stealth 360°® OAS	N/A

Detailed Description

This study is a prospective, single-arm (non-randomized), post-market study which will enroll up to 25 subjects. Intravascular Ultrasound (IVUS) imaging and angiography will be used to assess procedural outcomes in patients who have symptomatic peripheral artery disease who are treated with the Sponsor's OAS and adjunctive balloon angioplasty. An independent IVUS Core Lab will be used to provide adjudicated analyses for IVUS outcomes. In clinic follow-up visits will be performed at 2 weeks, 6 months and at 12 months.

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Tissue Removal Assessment With Ultrasound of THe SFA and Popliteal (TRUTH Study)
• Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Feb 1, 2015
• Actual Study Completion Date: Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: OAS + BA Cardiovascular Systems, Inc. Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA)	Device: Stealth 360°® OAS; Cardiovascular Systems, Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)

Outcome Measures

Primary Outcome Measures

1. Rate of Clinically Driven Target Lesion Revascularization (TLR) [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.

2. Mean Maximum Balloon Inflation Pressure [Index Procedure]

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

3. Rate of Procedural Angiographic Complications [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).

4. Ankle-Brachial Index (ABI) Measurments [Baseline, 2 weeks, 6 months and 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.

5. Rutherford Classification (RC) [Baseline, 2 weeks, 6 month and 12 month]

   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

6. Stent Usage at the Time of the Index Procedure [Index Procedure]

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

7. Percent (%) Area Stenosis [Index Procedure (pre-procedure, post-OAS treatment and post-balloon treatment)]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subject's age ≥ 18 years

• Subject is an acceptable candidate for percutaneous intervention using the Sponsor's OAS in accordance with its labeled indications and instructions for use

• Target lesion(s) located in a superficial femoral artery (SFA), popliteal (POP) or tibioperoneal trunk (TPT)

• Tight lesions (>70% stenosis)

• Lesions less than 110 mm in length

• Artery with the vessel < 6.5 mm in diameter

• Subject is willing and able to sign an approved informed consent form

• Subject is willing and able to attend follow-up visits

Exclusion Criteria:

• Uncontrolled allergy to nitinol, stainless-steel or other stent materials or to contrast agent

• Unable to take appropriate antiplatelet therapy

• Subject has no distal run-off

• Interventional treatment is intended for in-stent restenosis at the peripheral vascular site

• Subject has history of coagulopathy or hypercoagulable disorder, is undergoing hemodialysis or has impaired renal function (Cr > 2.5 mg/dl) at the time of treatment

• Female subject who is pregnant or nursing a child

• Intended interventional treatment includes planned laser, brachytherapy or atherectomy procedure other than the Sponsor's OAS

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

• Cardiovascular Systems Inc

Investigators

• Principal Investigator: Anvar Babaev, MD, NYU Langone Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cardiovascular Systems Inc
• ClinicalTrials.gov Identifier: NCT01938391
• Other Study ID Numbers: TRUTH
• First Posted: Sep 10, 2013
• Last Update Posted: Feb 12, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Cardiovascular Systems Inc: Peripheral Artery Disease; PAD; Claudication; Peripheral Vascular Disease; PVD; Orbital Atherectomy; Balloon Angioplasty; Intravascular Ultrasound (IVUS)
• Additional relevant MeSH terms: Vascular Diseases; Peripheral Arterial Disease; Intermittent Claudication; Peripheral Vascular Diseases

Study Results

Participant Flow

Arm/Group Title	Stealth 360°® OAS
Arm/Group Description	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)
Period Title: Baseline
STARTED	25
COMPLETED	25
NOT COMPLETED	0
Period Title: Baseline
STARTED	25
COMPLETED	25
NOT COMPLETED	0
Period Title: Baseline
STARTED	25
COMPLETED	24
NOT COMPLETED	1
Period Title: Baseline
STARTED	24
COMPLETED	22
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Stealth 360°® OAS
Arm/Group Description	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)
Overall Participants	25
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70.4 (7.8)
Sex: Female, Male (Count of Participants)
Female	6 24%
Male	19 76%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 8%
Not Hispanic or Latino	23 92%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 4%
White	24 96%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	25 100%
Number of treated lesions (lesions) [Number]
Number [lesions]	29

Outcome Measures

1. Primary Outcome

Title	Rate of Clinically Driven Target Lesion Revascularization (TLR)
Description	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.
Time Frame	6 months and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stealth 360°® OAS
Arm/Group Description	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)
Measure Participants	25
TLR at 6 months	4.0
TLR at 12 months	8.2

2. Primary Outcome

Title	Mean Maximum Balloon Inflation Pressure
Description	Mean maximum balloon inflation pressure of balloons used pre-stent placement.
Time Frame	Index Procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stealth 360°® OAS
Arm/Group Description	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)
Measure Participants	25
Measure balloons	31
Mean (Standard Deviation) [atm]	5.2 (1.2)

3. Primary Outcome

Title	Rate of Procedural Angiographic Complications
Description	Percent of study participants with an Investigator reported procedural angiographic complication (flow limiting dissection, perforation, slow flow/no flow, distal embolization and recoil).
Time Frame	Index Procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stealth 360°® OAS
Arm/Group Description	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)
Measure Participants	25
Flow limiting dissections (type D-F)	0 0%
Perforations	0 0%
Slow flow/no reflow	0 0%
Distal embolization	4 16%
Recoil	0 0%

4. Primary Outcome

Title	Ankle-Brachial Index (ABI) Measurments
Description	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.
Time Frame	Baseline, 2 weeks, 6 months and 12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Stealth 360°® OAS
Arm/Group Description	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)
Measure Participants	25
ABI at Baseline	0.74 (0.13)
ABI at 2 weeks	1.01 (0.10)
ABI at 6 months	0.96 (0.18)
ABI at 12 months	0.95 (0.15)

5. Primary Outcome

Title	Rutherford Classification (RC)
Description	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
Time Frame	Baseline, 2 weeks, 6 month and 12 month

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Stealth 360°® OAS
Arm/Group Description	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)
Measure Participants	25
RC 0 at baseline	0 0%
RC 0 at 2 weeks	24 96%
RC 0 at 6 month	19 76%
RC 0 at 12 month	13 52%
RC 1 at baseline	0 0%
RC 1 at 2 weeks	1 4%
RC 1 at 6 month	2 8%
RC 1 at 12 months	8 32%
RC 2 at baseline	0 0%
RC 2 at 2 weeks	0 0%
RC 2 at 6 month	0 0%
RC 2 at 12 months	1 4%
RC 3 at baseline	25 100%
RC 3 at 2 weeks	0 0%
RC 3 at 6 month	3 12%
RC 3 at 12 months	0 0%

6. Primary Outcome

Title	Stent Usage at the Time of the Index Procedure
Description	Number of lesions with a stent placed during the index procedure.
Time Frame	Index Procedure

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Stealth 360°® OAS
Arm/Group Description	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)
Measure Participants	25
Measure Lesions	29
Number [Lesions]	17

7. Primary Outcome

Title	Percent (%) Area Stenosis
Description	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).
Time Frame	Index Procedure (pre-procedure, post-OAS treatment and post-balloon treatment)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Stealth 360°® OAS
Arm/Group Description	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)
Measure Participants	25
Measure lesions	24
Pre-procedure, Area Stenosis (%)	76.9
Post-OAS treatment, Area Stenosis (%)	63.8
Post-Balloon treatment, Area Stenosis (%)	43.0

Adverse Events

Time Frame	AEs were collected during the index-procedure through 12 months of follow up.
Arm/Group Title	Stealth 360°® OAS
Arm/Group Description	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)
All Cause Mortality
	Stealth 360°® OAS
	Affected / at Risk (%)	# Events
Total	0/25 (0%)
Serious Adverse Events
	Stealth 360°® OAS
	Affected / at Risk (%)	# Events
Total	10/25 (40%)
Cardiac disorders
Chest Pain	1/25 (4%)	1
Injury, poisoning and procedural complications
Bleeding, access site	1/25 (4%)	1
Distal Embolization	4/25 (16%)	4
Dissection	2/25 (8%)	2
Vascular disorders
Worsening of PAD	2/25 (8%)	2
Other (Not Including Serious) Adverse Events
	Stealth 360°® OAS
	Affected / at Risk (%)	# Events
Total	11/25 (44%)
Injury, poisoning and procedural complications
Dissection	10/25 (40%)	10
Vascular disorders
Worsening of PAD	1/25 (4%)	1

Limitations/Caveats

TRUTH was a single center, non-randomized trial that enrolled a small number of subjects (25).

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.