Arterial Occlusive Diseases, Peripheral Arterial Disease, Peripheral Vascular Diseases
Conditions
Brief summary
The objective of this patient registry is to assess the clinical use of the Lutonix 035 DCB PTA Catheter in a heterogeneous patient population in a real world and on-label clinical application.
Detailed description
The registry is a prospective, multicenter, single arm post-market real-world registry in the U.S. assessing the clinical use, safety and outcomes of the Lutonix 035 DCB Catheter in the Superficial Femoral Artery (SFA) and Popliteal Arteries (PA). Registry subjects will be followed for up to three year's post-index procedure.
Interventions
DEVICEPTA (Lutonix® 035 DCB Catheter)
Percutaneous Transluminal Angioplasty (PTA) will involve the insertion of a catheter into one of the femoral arteries. Once the catheter is in place, a tiny balloon on the end of the catheter will be inflated to press against the narrowing (or blockage) in the artery to try to open the blockage, and allow more blood to flow through the artery. The balloon may need to be inflated several times in order for the narrowed area to open up sufficiently to improve the blood flow. The area will be viewed with specialized x-ray or other imaging devices to see if the artery has opened enough. The Lutonix® DCB through the blood vessel to the narrowed area to be treated.
Sponsors
C. R. Bard
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The subject provides written informed consent using an Informed Consent Form (ICF) that is reviewed and approved by the Institutional Review Board (IRB) for the site. 2. The subject agrees to comply with the protocol-mandated follow-up procedures and visits. 3. The subject is ≥ 21 years old. 4. The subject must have a lesion(s) that can be treated with available Lutonix 035 DCB Catheter according to IFU.
Exclusion criteria
1. The subject is unable or unwilling to provide informed consent. 2. The subject is unable or unwilling to comply with the patient registry protocol follow-up procedures and visits. 3. The subject has another medical condition or is currently participating in an investigational drug or an investigational device study that, which, in the opinion of the Investigator, may cause him/her to be non-compliant with the protocol, confounds the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of patient registry procedures and follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) at 12 Months Post Index Procedure | 12 months post-index procedure | TLR is defined as the first revascularization procedure (e.g. Percutaneous Transluminal Angioplasty (PTA), stenting, etc.) of the target lesion after the index procedure. |
| Percentage of Participants With Freedom From Composite of Device and/or Procedure Related Perioperative Death, Target Limb Major Amputation (Above the Ankle), and Target Vessel Revascularization) at 30 Days Post Index Procedure | 30 days post index procedure | Freedom from composite of device and/or procedure related perioperative (≤30 day) death, target limb major amputation (above the ankle), and target vessel revascularization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Acute Device and Procedural Success | At time of Index Procedure | Lesion success defined as attainment of \< 30% residual stenosis of the target lesion after the index procedure using any percutaneous method and/or non-investigational device (i.e., post-dilatation) and no peri-procedural complications (death, stroke, MI, emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel) prior to hospital discharge. |
| Percentage of Participants With Primary Patency at 12 Months Post Index Procedure | 12 months post-index procedure | The absence of target lesion restenosis (defined by Duplex Ultrasound (DUS) peak systolic velocity ratio (PSVR) ≥2.5) and freedom from Target Lesion Revascularization (TLR). Primary Patency at 12-Months post index-procedure by Kaplan-Meier estimates using a Method in which all subjects without a confirmed TLR or loss of patency were censored at Day 395 or the date of study discontinuation, whichever occurred first. |
| Percentage of Participants With Freedom From Target Vessel Revascularization (TVR) at 6, 12, 24, and 36 Months Post Index Procedure | 6 , 12, 24, and 36 months | TVR is defined as the first revascularization procedure (e.g. Percutaneous Transluminal Angioplasty (PTA), stenting, surgical bypass, etc.) in the target vessel after the index procedure (Kaplan-Meier estimates). |
| Percentage of Participants With Freedom From Major Amputation of the Target Limb (Above the Ankle Amputation) at 6, 12, 24, and 36 Months Post Index Procedure. | 6, 12, 24, and 36 Months Post Index Procedure | Freedom from major amputation of the target limb defined as above the ankle amputation |
| Percentage of Participants With Freedom From Composite of All-cause Perioperative (≤30 Day) Death and From the Following: Index Limb Amputation, Index Limb Reintervention, and Index-limb-related Death at 6, 12, 24, and 36 Months Post Index Procedure | 6, 12, 24, and 36 Months Post Index Procedure | Freedom from composite of all-cause perioperative (≤30 day) death and from the following: index limb amputation, index limb reintervention, and index-limb-related death (Kaplan-Meier estimates). |
| Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) at 6, 24, and 36 Months Post Index Procedure. | 6, 24, and 36 months post index procedure | TLR is defined as the first revascularization procedure (e.g. Percutaneous Transluminal Angioplasty (PTA), stenting, etc.) of the target lesion after the index procedure (Kapln-Meier estimates). |
Countries
United States
Participant flow
Recruitment details
Overall, 1005 subjects were enrolled and treated with the study device. A total of 966 subjects were included in the Per-Protocol population (excludes subjects with major protocol deviations) for final analysis.
Pre-assignment details
Between 2015 and 2017, Investigators treated 1005 subjects with the study device. Due to major protocol deviations, 39 subjects were excluded from the analyses conducted in this study. Therefore, the Per-Protocol population included 966 subjects and all outcome results and baseline data are based on this Per-Protocol population.
Participants by arm
| Arm | Count |
|---|---|
| PTA (Lutonix® 035 DCB Catheter) Treatment with the Lutonix 035 DCB will be per the investigational site's standard of care and adhering to the IFU.
PTA (Lutonix® 035 DCB Catheter): Percutaneous Transluminal Angioplasty (PTA) will involve the insertion of a catheter into one of the femoral arteries. Once the catheter is in place, a tiny balloon on the end of the catheter will be inflated to press against the narrowing (or blockage) in the artery to try to open the blockage, and allow more blood to flow through the artery. The balloon may need to be inflated several times in order for the narrowed area to open up sufficiently to improve the blood flow. The area will be viewed with specialized x-ray or other imaging devices to see if the artery has opened enough.
The Lutonix® DCB through the blood vessel to the narrowed area to be treated. | 966 |
| Total | 966 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 170 |
| Overall Study | Ineligible for Major Protocol Deviation | 39 |
| Overall Study | Investigator's decision | 44 |
| Overall Study | Lost to Follow-up | 81 |
| Overall Study | Other | 7 |
| Overall Study | Sponsor's decision | 3 |
| Overall Study | Withdrawal by Subject | 32 |
Baseline characteristics
| Characteristic | PTA (Lutonix® 035 DCB Catheter) |
|---|---|
| Age, Customized Age | 69.1 Years STANDARD_DEVIATION 9.79 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 56 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 910 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Number of Devices Used 1 device | 715 Participants |
| Number of Devices Used 2 devices | 203 Participants |
| Number of Devices Used 3 devices | 43 Participants |
| Number of Devices Used 4 devices | 5 Participants |
| Number of Target Lesions 1 Target Lesion | 744 Participants |
| Number of Target Lesions 2 Target Lesions | 178 Participants |
| Number of Target Lesions 3 Target Lesions | 39 Participants |
| Number of Target Lesions 4 Target Lesions | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 14 Participants |
| Race (NIH/OMB) Black or African American | 192 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 20 Participants |
| Race (NIH/OMB) White | 735 Participants |
| Region of Enrollment United States | 966 participants |
| Sex: Female, Male Female | 418 Participants |
| Sex: Female, Male Male | 548 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 173 / 1,005 |
| other Total, other adverse events | 121 / 1,005 |
| serious Total, serious adverse events | 65 / 1,005 |
Outcome results
Primary
Percentage of Participants With Freedom From Composite of Device and/or Procedure Related Perioperative Death, Target Limb Major Amputation (Above the Ankle), and Target Vessel Revascularization) at 30 Days Post Index Procedure
Freedom from composite of device and/or procedure related perioperative (≤30 day) death, target limb major amputation (above the ankle), and target vessel revascularization.
Time frame: 30 days post index procedure
Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PTA (Lutonix® 035 DCB Catheter) | Percentage of Participants With Freedom From Composite of Device and/or Procedure Related Perioperative Death, Target Limb Major Amputation (Above the Ankle), and Target Vessel Revascularization) at 30 Days Post Index Procedure | 98.2 Percentage of Participants |
Primary
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) at 12 Months Post Index Procedure
TLR is defined as the first revascularization procedure (e.g. Percutaneous Transluminal Angioplasty (PTA), stenting, etc.) of the target lesion after the index procedure.
Time frame: 12 months post-index procedure
Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PTA (Lutonix® 035 DCB Catheter) | Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) at 12 Months Post Index Procedure | 88.6 percentage of participants |
Secondary
Percentage of Participants With Acute Device and Procedural Success
Lesion success defined as attainment of \< 30% residual stenosis of the target lesion after the index procedure using any percutaneous method and/or non-investigational device (i.e., post-dilatation) and no peri-procedural complications (death, stroke, MI, emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel) prior to hospital discharge.
Time frame: At time of Index Procedure
Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PTA (Lutonix® 035 DCB Catheter) | Percentage of Participants With Acute Device and Procedural Success | 93.0 Percentage of Participants |
Secondary
Percentage of Participants With Freedom From Composite of All-cause Perioperative (≤30 Day) Death and From the Following: Index Limb Amputation, Index Limb Reintervention, and Index-limb-related Death at 6, 12, 24, and 36 Months Post Index Procedure
Freedom from composite of all-cause perioperative (≤30 day) death and from the following: index limb amputation, index limb reintervention, and index-limb-related death (Kaplan-Meier estimates).
Time frame: 6, 12, 24, and 36 Months Post Index Procedure
Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PTA (Lutonix® 035 DCB Catheter) | Percentage of Participants With Freedom From Composite of All-cause Perioperative (≤30 Day) Death and From the Following: Index Limb Amputation, Index Limb Reintervention, and Index-limb-related Death at 6, 12, 24, and 36 Months Post Index Procedure | 6 months post index procedure | 90.3 Percentage of Participants |
| PTA (Lutonix® 035 DCB Catheter) | Percentage of Participants With Freedom From Composite of All-cause Perioperative (≤30 Day) Death and From the Following: Index Limb Amputation, Index Limb Reintervention, and Index-limb-related Death at 6, 12, 24, and 36 Months Post Index Procedure | 12 months post index procedure | 80.8 Percentage of Participants |
| PTA (Lutonix® 035 DCB Catheter) | Percentage of Participants With Freedom From Composite of All-cause Perioperative (≤30 Day) Death and From the Following: Index Limb Amputation, Index Limb Reintervention, and Index-limb-related Death at 6, 12, 24, and 36 Months Post Index Procedure | 24 months post index procedure | 67.4 Percentage of Participants |
| PTA (Lutonix® 035 DCB Catheter) | Percentage of Participants With Freedom From Composite of All-cause Perioperative (≤30 Day) Death and From the Following: Index Limb Amputation, Index Limb Reintervention, and Index-limb-related Death at 6, 12, 24, and 36 Months Post Index Procedure | 36 Months Post Index Procedure | 58.4 Percentage of Participants |
Secondary
Percentage of Participants With Freedom From Major Amputation of the Target Limb (Above the Ankle Amputation) at 6, 12, 24, and 36 Months Post Index Procedure.
Freedom from major amputation of the target limb defined as above the ankle amputation
Time frame: 6, 12, 24, and 36 Months Post Index Procedure
Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PTA (Lutonix® 035 DCB Catheter) | Percentage of Participants With Freedom From Major Amputation of the Target Limb (Above the Ankle Amputation) at 6, 12, 24, and 36 Months Post Index Procedure. | 36 Months post Index Procedure | 95.6 Percentage of Participants |
| PTA (Lutonix® 035 DCB Catheter) | Percentage of Participants With Freedom From Major Amputation of the Target Limb (Above the Ankle Amputation) at 6, 12, 24, and 36 Months Post Index Procedure. | 6 months post index procedure | 98.5 Percentage of Participants |
| PTA (Lutonix® 035 DCB Catheter) | Percentage of Participants With Freedom From Major Amputation of the Target Limb (Above the Ankle Amputation) at 6, 12, 24, and 36 Months Post Index Procedure. | 12 months post index procedure | 97.5 Percentage of Participants |
| PTA (Lutonix® 035 DCB Catheter) | Percentage of Participants With Freedom From Major Amputation of the Target Limb (Above the Ankle Amputation) at 6, 12, 24, and 36 Months Post Index Procedure. | 24 months post index procedure | 96.6 Percentage of Participants |
Secondary
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) at 6, 24, and 36 Months Post Index Procedure.
TLR is defined as the first revascularization procedure (e.g. Percutaneous Transluminal Angioplasty (PTA), stenting, etc.) of the target lesion after the index procedure (Kapln-Meier estimates).
Time frame: 6, 24, and 36 months post index procedure
Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PTA (Lutonix® 035 DCB Catheter) | Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) at 6, 24, and 36 Months Post Index Procedure. | 6 months post index procedure | 95.9 Percentage of Participants |
| PTA (Lutonix® 035 DCB Catheter) | Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) at 6, 24, and 36 Months Post Index Procedure. | 24 months post index procedure | 79.8 Percentage of Participants |
| PTA (Lutonix® 035 DCB Catheter) | Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) at 6, 24, and 36 Months Post Index Procedure. | 36 Months Post Index Procedure | 74.4 Percentage of Participants |
Secondary
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR) at 6, 12, 24, and 36 Months Post Index Procedure
TVR is defined as the first revascularization procedure (e.g. Percutaneous Transluminal Angioplasty (PTA), stenting, surgical bypass, etc.) in the target vessel after the index procedure (Kaplan-Meier estimates).
Time frame: 6 , 12, 24, and 36 months
Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PTA (Lutonix® 035 DCB Catheter) | Percentage of Participants With Freedom From Target Vessel Revascularization (TVR) at 6, 12, 24, and 36 Months Post Index Procedure | 6 months post index procedure | 94.7 Percentage of participants |
| PTA (Lutonix® 035 DCB Catheter) | Percentage of Participants With Freedom From Target Vessel Revascularization (TVR) at 6, 12, 24, and 36 Months Post Index Procedure | 12 months post index procedure | 86.5 Percentage of participants |
| PTA (Lutonix® 035 DCB Catheter) | Percentage of Participants With Freedom From Target Vessel Revascularization (TVR) at 6, 12, 24, and 36 Months Post Index Procedure | 24 months post index procedure | 75.7 Percentage of participants |
| PTA (Lutonix® 035 DCB Catheter) | Percentage of Participants With Freedom From Target Vessel Revascularization (TVR) at 6, 12, 24, and 36 Months Post Index Procedure | 36 Months Post Index Procedure | 69.5 Percentage of participants |
Secondary
Percentage of Participants With Primary Patency at 12 Months Post Index Procedure
The absence of target lesion restenosis (defined by Duplex Ultrasound (DUS) peak systolic velocity ratio (PSVR) ≥2.5) and freedom from Target Lesion Revascularization (TLR). Primary Patency at 12-Months post index-procedure by Kaplan-Meier estimates using a Method in which all subjects without a confirmed TLR or loss of patency were censored at Day 395 or the date of study discontinuation, whichever occurred first.
Time frame: 12 months post-index procedure
Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PTA (Lutonix® 035 DCB Catheter) | Percentage of Participants With Primary Patency at 12 Months Post Index Procedure | 83.7 Percentage of Participants |