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| General |
| Study Status |
Progress Adequate |
Application Number /
Requirement Number |
P150028 / PAS002 |
| Date Original Protocol Accepted |
03/25/2016
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| Date Current Protocol Accepted |
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| Study Name |
Cont f/u of premarket cohorts w/stent fra
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| Device Name |
CHEATHAM PLATINUM (CP) STENT SYSTEM (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent)
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Objective Performance Criterion
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| Analysis Type |
Descriptive
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| Study Population |
Child: 2-12 yrs,
Adolescent: 13-18 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
This study should include all currently enrolled and alive patients in the COAST and COAST II studies with stent fractures and COAST CAP and COAST II CAP studies with stent fractures who had completed 2-year follow-up at the time of PMA submission.
The objective of this study is to evaluate the long-term safety and effectiveness of the CP Stents and Covered CP Stents in patients with stent fractures through ten years post-implant.
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| Study Population |
This study should include all currently enrolled and alive patients in the COAST and COAST II studies with stent fractures and COAST CAP and COAST II CAP studies with stent fractures who had completed 2-year follow-up at the time of PMA submission.
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| Sample Size |
The following describes each study from which the patients will be selected, based on the presence of stent fractures, as described in the Study Population section above:
COAST:
112 safety cohort patients, 105 effectiveness cohort patients
The trial will be considered a success if the hypotheses relating to all four primary outcomes are confirmed.
Primary Safety:
1) Occurrence of any serious or somewhat serious adverse event attributed to the stent or implantation procedure within 30 days of the catheterization procedure.
2) Occurrence of post-procedure paradoxical hypertension.
Primary Effectiveness:
1) Reduction in arm-leg systolic blood pressure gradient from pre-dilation to the 12 month post-dilation follow-up.
2) Length of stay in the hospital, measured in days.
The following table from the COAST Protocol V4 displays the power calculations and assumptions associated with each primary outcome.
COAST CAP:
Total of 16 possible patients in safety and effectiveness cohorts. Only 8 patients completed 2 year follow-up at the time of the PMA submission. Two stent fractures were observed in the COAST CAP, representing 16.7% of the subjects. There was loss of structural integrity in one patient. These two patients would likely be included in the PAS.
COAST II:
82 patients enrolled for safety cohort and effectiveness cohort
The trial will be considered a success if the hypotheses relating to all primary outcomes are confirmed.
Primary Safety: Occurrence of any serious or somewhat serious adverse event attributed to the stent or implantation procedure within 30 days of the catheterization procedure.
Primary Effectiveness:
1) Improvement of aortic wall injury and/or aortic arch obstruction by a median increase of at least one grade from pre-implantation baseline to 12-month follow-up using the Severity of Illness Scale (based on upper extremity (UE) systolic BP, UE to lower extremity (LE) systolic BP, and aortic wall injury).
2) Aortic wall injury and aortic arch obstruction at Grade 4 or above at the 12-month follow-up, based on the Severity of Illness Scale, with no clinical worsening.
The following table from the COAST II Protocol V2 displays the power calculations and assumptions associated with each primary outcome.
COAST II CAP:
Total of 45 possible patients in the safety and effectiveness cohorts. Only 16 patients completed 2-year follow-up at the time of the PMA submission. One stent fracture was observed in the COAST II CAP, which did not result in loss of structural integrity. This patient would likely be included in the PAS.
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| Key Study Endpoints |
COAST:
Primary Safety Endpoint #1: Occurrence of any serious or somewhat serious adverse event attributed to the stent or implantation procedure within 30 days of the catheterization procedure.
Primary Safety Endpoint #2: Occurrence of post-procedure paradoxical hypertension.
Primary Effectiveness Endpoint #1: Reduction in arm-leg systolic blood pressure gradient from pre-dilation to the 12-month post-dilation follow-up.
Primary Effectiveness Endpoint #2: Length of stay in the hospital, measured in days
COAST CAP:
The primary safety endpoints were the occurrence of device or implant related serious adverse events and the occurrence of post-procedure paradoxical hypertension. The primary effectiveness endpoints were reduction in arm-leg systolic blood pressure gradient and length of stay in the hospital.
COAST II:
Primary Safety Endpoint: Occurrence of any serious or somewhat serious adverse event attributed to the stent or implantation procedure within 30 days of the catheterization procedure.
Secondary Safety Endpoint: Proportion of patients experiencing any of the following adverse events related to the device or implant procedure post 1 year
Underlying cardiac or non-cardiac disease, aortic wall injury, new aortic aneurysm formation within region of device, stent misplacement, malposition, stent fracture, aortic wall aneurysms, or restenosis requiring reintervention.
Primary Effectiveness Endpoint #1: Improvement of aortic wall injury and/or aortic arch obstruction by a median increase of at least one grade from pre-implantation baseline to 12-month follow-up using the Severity of Illness Scale (based on upper extremity (UE) systolic BP, UE to lower extremity (LE) systolic BP, and aortic wall injury).
Primary Effectiveness Endpoint #2: Aortic wall injury and aortic arch obstruction at Grade 4 or above at the 12-month follow-up, based on the Severity of Illness Scale, with no clinical worsening.
COAST II CAP:
The primary safety endpoint was the occurrence of device- or procedure- related serious adverse events. The primary effectiveness endpoint was improvement of aortic wall injury and/or aortic arch obstruction.
In addition, the FDA requested reporting of the following outcomes annually:
Blood pressure outcomes:
i. Percent of patients with:
1. Systolic blood pressure (SBP) arm-leg differences under 20, 15 and 10 mmHg;
2. Average arm leg SBP difference; and
3. Proportion of patients with hypertension.
b. Aortic Wall Injury (AWI) Outcomes:
i. Clinical summaries for any patient with new or progressive AWI requiring follow-up imaging, intervention or surgery (imaging performed on a clinical basis ? descriptive summary only); and
ii. Overall incidence of patients detected with new or progressive AWI (using baseline sample size as denominator).
c. Stent Fracture Outcomes:
i. Any new or progressive stent fracture;
ii. Total incidence of stent fracture for bare metal and covered stents (using baseline sample size as denominator);
iii. Descriptive summaries for each stent fracture, including need for re-intervention or surgery; and
iv. Total incidence and types of late sequelae (e.g., none, recoarctation, pseudoaneurysm, aortic perforation, etc.).
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| Follow-up Visits and Length of Follow-up |
10 years
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