Claudication, PAD, Peripheral Artery Disease, Peripheral Vascular Disease, PVD
Conditions
Keywords
Peripheral Artery Disease, PAD, Claudication, Peripheral Vascular Disease, PVD, Orbital Atherectomy, Balloon Angioplasty, Intravascular Ultrasound (IVUS)
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).
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.
Interventions
DEVICEStealth 360°® OAS
Cardiovascular Systems, Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)
Sponsors
Abbott Medical Devices
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Mean Maximum Balloon Inflation Pressure | Index Procedure | Mean maximum balloon inflation pressure of balloons used pre-stent placement. |
| 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). |
| 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. |
| 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 |
| Stent Usage at the Time of the Index Procedure | Index Procedure | Number of lesions with a stent placed during the index procedure. |
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 12 Month Follow up | Physician Decision | 1 |
| 12 Month Follow up | Withdrawal by Subject | 1 |
| 6 Month Follow up | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Stealth 360°® OAS |
|---|---|
| Age, Continuous | 70.4 years STANDARD_DEVIATION 7.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Number of treated lesions | 29 lesions |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 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 | 24 Participants |
| Region of Enrollment United States | 25 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 11 / 25 |
| serious Total, serious adverse events | 10 / 25 |
Outcome results
Primary
Ankle-Brachial Index (ABI) Measurments
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stealth 360°® OAS | Ankle-Brachial Index (ABI) Measurments | ABI at Baseline | 0.74 ratio | Standard Deviation 0.13 |
| Stealth 360°® OAS | Ankle-Brachial Index (ABI) Measurments | ABI at 2 weeks | 1.01 ratio | Standard Deviation 0.1 |
| Stealth 360°® OAS | Ankle-Brachial Index (ABI) Measurments | ABI at 6 months | 0.96 ratio | Standard Deviation 0.18 |
| Stealth 360°® OAS | Ankle-Brachial Index (ABI) Measurments | ABI at 12 months | 0.95 ratio | Standard Deviation 0.15 |
Primary
Mean Maximum Balloon Inflation Pressure
Mean maximum balloon inflation pressure of balloons used pre-stent placement.
Time frame: Index Procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stealth 360°® OAS | Mean Maximum Balloon Inflation Pressure | 5.2 atm | Standard Deviation 1.2 |
Primary
Percent (%) Area Stenosis
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)
Population: At the time of analysis 24 of 29 lesions in 25 participants could be assess by the IVUS Core Lab.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Stealth 360°® OAS | Percent (%) Area Stenosis | Pre-procedure, Area Stenosis (%) | 76.9 percent area stenosis |
| Stealth 360°® OAS | Percent (%) Area Stenosis | Post-OAS treatment, Area Stenosis (%) | 63.8 percent area stenosis |
| Stealth 360°® OAS | Percent (%) Area Stenosis | Post-Balloon treatment, Area Stenosis (%) | 43.0 percent area stenosis |
Primary
Rate of Clinically Driven Target Lesion Revascularization (TLR)
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stealth 360°® OAS | Rate of Clinically Driven Target Lesion Revascularization (TLR) | TLR at 6 months | 4.0 % probablity of clinically driven TLR |
| Stealth 360°® OAS | Rate of Clinically Driven Target Lesion Revascularization (TLR) | TLR at 12 months | 8.2 % probablity of clinically driven TLR |
Primary
Rate of Procedural Angiographic Complications
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stealth 360°® OAS | Rate of Procedural Angiographic Complications | Flow limiting dissections (type D-F) | 0 Participants |
| Stealth 360°® OAS | Rate of Procedural Angiographic Complications | Perforations | 0 Participants |
| Stealth 360°® OAS | Rate of Procedural Angiographic Complications | Slow flow/no reflow | 0 Participants |
| Stealth 360°® OAS | Rate of Procedural Angiographic Complications | Distal embolization | 4 Participants |
| Stealth 360°® OAS | Rate of Procedural Angiographic Complications | Recoil | 0 Participants |
Primary
Rutherford Classification (RC)
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
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stealth 360°® OAS | Rutherford Classification (RC) | RC 2 at 6 month | 0 Participants |
| Stealth 360°® OAS | Rutherford Classification (RC) | RC 2 at 12 months | 1 Participants |
| Stealth 360°® OAS | Rutherford Classification (RC) | RC 3 at baseline | 25 Participants |
| Stealth 360°® OAS | Rutherford Classification (RC) | RC 0 at baseline | 0 Participants |
| Stealth 360°® OAS | Rutherford Classification (RC) | RC 0 at 2 weeks | 24 Participants |
| Stealth 360°® OAS | Rutherford Classification (RC) | RC 0 at 6 month | 19 Participants |
| Stealth 360°® OAS | Rutherford Classification (RC) | RC 0 at 12 month | 13 Participants |
| Stealth 360°® OAS | Rutherford Classification (RC) | RC 1 at baseline | 0 Participants |
| Stealth 360°® OAS | Rutherford Classification (RC) | RC 1 at 2 weeks | 1 Participants |
| Stealth 360°® OAS | Rutherford Classification (RC) | RC 1 at 6 month | 2 Participants |
| Stealth 360°® OAS | Rutherford Classification (RC) | RC 1 at 12 months | 8 Participants |
| Stealth 360°® OAS | Rutherford Classification (RC) | RC 2 at baseline | 0 Participants |
| Stealth 360°® OAS | Rutherford Classification (RC) | RC 2 at 2 weeks | 0 Participants |
| Stealth 360°® OAS | Rutherford Classification (RC) | RC 3 at 2 weeks | 0 Participants |
| Stealth 360°® OAS | Rutherford Classification (RC) | RC 3 at 6 month | 3 Participants |
| Stealth 360°® OAS | Rutherford Classification (RC) | RC 3 at 12 months | 0 Participants |
Primary
Stent Usage at the Time of the Index Procedure
Number of lesions with a stent placed during the index procedure.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stealth 360°® OAS | Stent Usage at the Time of the Index Procedure | 17 Lesions |