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|
| General |
| Study Status |
Terminated |
Application Number /
Requirement Number |
P000018 / PAS001 |
| Date Original Protocol Accepted |
11/03/2000
|
| Date Current Protocol Accepted |
02/23/2011
|
| Study Name |
Beta-Cath Long Term
|
| Device Name |
BETA-CATH (TM) SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Retrospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The study was initially designed as a prospective study. However, due to the inability to prospectively recruit patients, the study design was modified. The current design is a single site retrospective study of the long term safety and effectiveness of the Beta Cath 3.5F system.
|
| Study Population |
Patients treated with the BethCath 3.5F System. These patients receive beta radiation to the site of successful percutaneous coronary intervention for the treatment of in-stent restenosis in native coronary arteries with discrete lesions in a reference vessel diameter ranging from 2.7 to 4.0 mm.
|
| Sample Size |
200 patients, 1 site
|
| Key Study Endpoints |
The primary safety endpoints are: (1) Incidence of device related procedural events and (2) major adverse events at each study point. The primary efficacy endpoints are: 1) device success including successful delivery of source train, return of source train and delivery of intended dose and 2) target vessel revascularization.
|
| Follow-up Visits and Length of Follow-up |
Patients will be followed clinically at 6 months, 1, 2, 3, 4, and 5 years post treatment. Due to retrospective enrollment, patients may be enrolled at any of the specified time points and followed for subsequent visits.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
One hundred and twenty-eight (128) of 200 required subjects were enrolled.
|
| Actual Number of Sites Enrolled |
One (1) site enrolled for this study.
|
| Patient Follow-up Rate |
At 5 years the follow-up rates were 91.0% (71/78) for 3.5F PAS 30/40mm group and 92.0%
(46/50) for 3.5F PAS 60 mm group.
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| Final Safety Findings |
The safety endpoints for both 3.5F PAS 30/40mm and 3.5F PAS 60mm groups are
1) Incidence of device-related procedural events (Aneurysm)
2) Major Adverse cardiac event (MACE) in-hospital and at 30 days, 6 months, and annually 5
years post -treatment
The effectiveness endpoints for both 3.5F 30/40mm PAS and 3.5F 60mm PAS are
1) Device success, including successful delivery of the source train, return of the source train,
and delivery of the intended dose, and
2) Target vessel revascularization (TVR) at 6 months and annually, through 5 years posttreatment.
Per protocol the 3.5F PAS 30/40mm data were compared to the historical START and START
40/20 Post Approval Studies (which reported long term data for the 5F Beta-Cath 30mm and
40mm Systems), and the 3.5F PAS 60mm data were compared to the historical RENO Long data.
Safety: 3.5F PAS 30/40mm Group
The reported aneurysm rate at 5 years for the 3.5 F PAS 30/40mm group was 0.0% (0/15).
The cumulative Major Adverse Cardiac Events (MACE) rate at 5 years by Kaplan Meier estimate
for the 3.5F PAS 30/40mm group was 64.2%.
The cumulative MACE rate for 3.5F PAS 30/40mm compared to START Placebo, START Sr-
90 or START 40 Sr-90 was not statistically significant at any of the timepoint.
|
| Final Effect Findings |
Effectiveness: 3.5F PAS 30/40mm Group
The device success rates for the 3.5F PAS 30/40mm group was 98.7% (77/78).
The cumulative target lesion revascularization (TVR) rates at 5 years by Kaplan Meier
estimate for the 3.5F PAS 30/40mm group was 48.3%.
The cumulative TVR rate was significantly higher in the 3.5F PAS 30/40mm group compared to
START Sr-90 [40mm] Group at the following time points:
At 3 years, the cumulative TVR rate was 39.7% (31/78) in 3.5F PAS 30/40mm group vs.
16.5% (26/158) in START Sr-90 [40mm] (p< 0.001).
At 4 years, the cumulative TVR rate was 46.9% (36/78) in 3.5F PAS 30/40mm group vs.
16.9% (26/154) in START Sr-90 [40mm], (p<0.001).
At 5 years, the cumulative TVR rate was 48.3% (37/78) in 3.5F PAS 30/40mm group vs.
19.0% (27/142) in START Sr-90[40mm] (p<0.001).
The cumulative TVR rate in the 3.5F PAS 30/40mm group, 39.7 % (31/78), was significantly
lower compared to the rate in the START Placebo group, 56.5% (87/154) (p=0.0159) at 3 years
only.
The cumulative TVR rate in START Sr-90 [30mm] compared to 3.5F PAS 30/40mm group was not
statistically significant at any time point.
Safety: 3.5F PAS 60mm Group
The reported aneurysm rate at 5 years for the 3.5 F PAS 60mm group was 0.0% (0/9).
The MACE rate at 5 years for the 3.5F PAS 60mm group was 15.2% (7/46).
The MACE rate for RENO-Long data at 6 months, 17.9% (24/134) was significantly higher
compared to 3.5F 60mm PAS (< 1year data) 4.0% (2/50), p=0.0160.
Effectiveness: 3.5F PAS 60mm Group
The device success rate for the 3.5F PAS 60mm group was 100% (50/50).
The TVR rate for 3.5F PAS 60mm group at 5 years 6.5% (3/46).
The TVR rate for RENO-Long data at 6 months, 14.9% (20/134) was significantly higher
compared to 3.5F 60mm PAS data (< 1 year) 4.0% (2/50), (p=0.0435).
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| Study Strengths & Weaknesses |
The study endpoints of MACE, TVR and device-related procedural events (aneurysm) for both
3.5F PAS 30/40mm and 3.5F PAS 60mm groups were collected through 5 years. At 5 years, data
was available for assessment of MACE and TVR in over 90% of patients.
The study was initially designed as a prospective study but was later modified per protocol to
be a retrospective study enrolling patients from a single site. Enrollment in the study could not
be completed, and a study based on a single center may have limited generalizability to the
general patient population. The retrospective nature of the study designs can introduce recall
biases on the assessment of exposure and identification of important endpoints.
There were also missing data on follow-up diagnostic catherization in the assessment of safety
endpoint, incidence of device-related procedural events (aneurysms).
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| Recommendations for Labeling Changes |
Labeling update is not recommended because subject enrollment could not be completed and
there is limited use of the device on label.
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