|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P130024 / PAS001 |
| Date Original Protocol Accepted |
10/09/2014
|
| Date Current Protocol Accepted |
11/28/2017
|
| Study Name |
PAS 1 (Extended Follow-up Study)
|
| Device Name |
LUTONIX DRUG COATED BALLOON PTA CATETER
|
| Clinical Trial Number(s) |
NCT00930813 NCT01412541 NCT01628159 NCT01790243
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Prospective cohort study, continued follow-up of premarket cohorts and LEVANT 2 Safety Registry subjects
|
| Study Population |
Patients treated with the Lutonix DCB for stenosis of the femoropopliteal artery
|
| Sample Size |
657 DCB subjects from the LEVANT 2 Safety Registry
372 DCB subjects from the LEVANT 2 Pivotal IDE study
160 PTA controls from the LEVANT 2 Pivotal IDE study
The assumption is that results at 2 years will be proportionally similar in DCB subjects and controls to what
they were in the pivotal IDE study. The PAS study will have a much larger sample size and therefor greater power than that of the pivotal IDE study.
|
| Key Study Endpoints |
Primary effectiveness: Primary patency of the target lesion
at 24 months
Primary safety: Composite freedom for all cause
perioperative (within 30 days), index limb amputation (2
years), index limb re-intervention (2 years), and index limbrelated death (2 years)
Secondary endpoints: Individual components of the primary
safety endpoint, device- and drug-related adverse events,
all-cause death, major vascular complications, target lesion
revascularization, and Rutherford classification
|
| Follow-up Visits and Length of Follow-up |
5 years Clinical follow-up, including Duplex Ultrasound (DUS) will be
done at 6 months, 12 months, and 24 months. Telephone
f/u will be done at 1 month, 3, 4, and 5 years.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
Actual number of subjects enrolled:
DCB Subjects (1029)
Control Subjects (160)
This includes: LEVANT 2 Safety Registry patients (n=657), LEVANT 2 randomized DCB (n=316) and
LEVANT 2 randomized roll-in (n=56) compared against the results from the LEVANT 2 randomized
control PTA (n=160).
|
| Actual Number of Sites Enrolled |
74
|
| Patient Follow-up Rate |
DCB Subjects 86% (143/1029)
Control Subjects 84% (26/160)
Lost to follow up plus withdrew from study.
|
| Final Safety Findings |
The composite of freedom from all-cause perioperative death (=
30 days) and index limb amputation (including above or below the knee), index limb reintervention,
or index limb related death through 24 months was 74.7% (674/902) for the DCB group
and 67.1% (94/140) for the PTA group. The DCB group has a higher freedom from the composite
safety endpoint rate of 6.4% through the 24 months follow-up.
|
| Final Effect Findings |
Primary patency of the target lesion at 24 months was
54.5% (458/841) for the DCB group and 47.2% (60/127) for the control group. The DCB group
demonstrated a higher rate of primary patency, approximately 6.4%, over the PTA group throughout 24
months.
|
| Study Strengths & Weaknesses |
The strengths of the study include randomization against an appropriate control and adequate and
extended follow up. Study weaknesses include increase mortality for the test device versus control after
two years in the randomized patients
|
| Recommendations for Labeling Changes |
yes
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P130024 / PAS002 |
| Date Original Protocol Accepted |
10/09/2014
|
| Date Current Protocol Accepted |
11/09/2018
|
| Study Name |
(New Enroll of Female Pt Study)SAFE-DCB RW US Std
|
| Device Name |
LUTONIX DRUG COATED BALLOON PTA CATETER
|
| Clinical Trial Number(s) |
NCT00930813 NCT01412541 NCT01628159 NCT01790243
|
| General Study Protocol Parameters |
| Study Design |
Other Study Design
|
| Data Source |
Other Data Source
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Objective: To evaluate the safety and effectiveness of the Lutonix Catheter for treatment of stenosis of the femoropopliteal arteries in the US female population.
The originally designed study (CONFIRM) was a prospective, multicenter, randomized study. The sponsor had difficulty enrolling for numerous years since approval. The sponsor noted the following reasons regarding the difficulty in enrollment:
“Enrollment as a randomized study is not feasible due to the following:
• Ethically, IRB approval would be difficult as this study is requiring randomization of patients to POBA which is known to be inferior to a commercially available drug coated balloon...
• Patient consent would be difficult given the commercial availability of DCBs, clinical outcomes of the DCBs, and the potential for randomization to POBA.”
In order to help with enrollment, this study was later changed to a single-arm study with a performance goal prior to enrolling any patients. Yet, the study continued to have enrollment issues, enrolling only 4 subjects 4 years after approval. At this time, it was ultimately decided by FDA and Lutonix that retrospective analysis of the female patients in their SAFE-DCB real world US registry would be the only way to get results for this evaluation in a timely manner.
The design and results from the SAFE-DCB registry are described below.
|
| Study Population |
US patients presenting with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery. Subjects are treated per IFU with the Lutonix Catheter.
|
| Sample Size |
Approximately 1005 patients were enrolled at 74 US sites.
|
| Key Study Endpoints |
The primary safety endpoint is the composite of freedom from device and/or procedure related peri-operative (less than or equal to 30 day) death and freedom at 1 year from the following: target limb major amputation (above the ankle), and target vessel revascularization (TVR).
The primary effectiveness endpoint is target lesion revascularization (TLR) at 12 months.
|
| Follow-up Visits and Length of Follow-up |
36 months
1, 6, 12, 24 and 36 months
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
1005 (418 female)
|
| Actual Number of Sites Enrolled |
74
|
| Patient Follow-up Rate |
79.3%
|
| Final Safety Findings |
Freedom from Primary Safety Event
DCB Overall Population - 98.2% (937/954) [97.2%,99.0%]
DCB Female Subgroup - 97.8% (401/410) [95.9%,99.0%]
Comparison to LEVANT 2 Pivotal Study
DCB Overall Population - 99.4% (306/308) [98.5%, 100.0%]
DCB Female Subgroup – Not analyzed
|
| Final Effect Findings |
Freedom from TLR
DCB Overall population - 88.8% (763/859) [86.5%, 90.9%]
DCB Female Subgroup - 86.4% (325/376) [82.6%, 89.7%]
Comparison to LEVANT 2 Pivotal Study
DCB Overall population - 87.7% (250/285) [83.9%, 91.5%]
DCB Female Subgroup - 83.2% (119/143) [78.2%, 91.5%]
|
| Study Strengths & Weaknesses |
Strengths:
Large sample size
Real-world population
Weaknesses:
Single Arm Trial
Lack of imaging
Retrospective analysis
|
| Recommendations for Labeling Changes |
NONE
|
