Renal Artery Stenosis
Conditions
Keywords
renal artery stenosis, hypertension, renovascular, renal artery blockage, renal artery disease, renal arteries, angioplasty renal artery, renal artery stent, renal artery doppler, renovascular hypertension, kidney stenosis, renal artery, stent, stenting, kidney disease, renal failure, atherosclerosis, arterial hypertension, stenosis
Brief summary
The purpose of the study is to evaluate the safety and effectiveness of the Formula Balloon-Expandable Stent in treatment of renal artery stenosis.
Interventions
DEVICEFormula Balloon-Expandable Stent
renal artery stenting
Sponsors
Cook Group Incorporated
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
Key Inclusion Criteria: * renal artery stenosis * appropriate size and location of the lesion * suboptimal angioplasty Key
Exclusion criteria
* less than 18 years old * failure or inability to give informed consent * simultaneously participating in another drug or device study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Patency of the Treated Renal Artery | 9 Months | Based on ultrasound images assessed by core lab. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With 30-day Major Adverse Events | 30 Days | Clinical Events Committee Adjudicated Death, Clinical Events Committee Adjudicated Q-wave MI, Clinically-driven Target Lesion Revascularization, Clinical Events Committee Adjudicated Significant Embolic Events. |
| Number of Participants With 9-month Major Adverse Events | 9 Months | Clinical Events Committee Adjudicated Death, Clinical Events Committee Adjudicated Q-wave MI, Clinically-driven Target Lesion Revascularization, Clinical Events Committee Adjudicated Significant Embolic Events. |
| Technical Success | Prior to Discharge | Successful delivery and deployment of a Formula™ Balloon-Expandable Stent at index procedure. |
| Acute Procedural Success | Prior to Discharge | \< 30% residual stenosis post-procedure by core lab analysis and no Major Adverse Events before discharge. |
| 30-day Clinical Success | 30 Days | \< 30% residual stenosis post-procedure by core lab analysis and no Major Adverse Events within 30 days. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Formula™ Balloon-Expandable Renal Stent renal artery stenting | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Core Lab Data Unavailable | 3 |
| Overall Study | Death | 4 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Formula™ Balloon-Expandable Renal Stent |
|---|---|
| Age, Continuous | 72 Years STANDARD_DEVIATION 10 |
| Congestive Heart Failure Congestive Heart Failure | 26 Participants |
| Congestive Heart Failure No Congestive Heart Failure | 74 Participants |
| Diastolic Blood Pressure | 73.9 mmHg STANDARD_DEVIATION 12.9 |
| Estimated Glomerular Filtration Rate | 60.7 ml/min STANDARD_DEVIATION 28.8 |
| Hypertension Hypertension | 97 Participants |
| Hypertension No Hypertension | 3 Participants |
| Number of Antihypertensive Medications per Patient | 2.7 Antihypertensive Medications STANDARD_DEVIATION 1.2 |
| Percent Stenosis at Baseline Core Lab | 57.4 Percent STANDARD_DEVIATION 13.8 |
| Percent Stenosis at Baseline Site Reported | 82.5 Percent STANDARD_DEVIATION 8.1 |
| Region of Enrollment United States | 100 Participants |
| Renal Insufficiency No Renal Insufficiency | 54 Participants |
| Renal Insufficiency Renal Insufficiency | 46 Participants |
| Serum Creatinine | 1.3 mg/dl STANDARD_DEVIATION 0.5 |
| Sex: Female, Male Female | 56 Participants |
| Sex: Female, Male Male | 44 Participants |
| Systolic Blood Pressure | 150.3 mmHg STANDARD_DEVIATION 20.6 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 11 / 99 |
| serious Total, serious adverse events | 0 / 100 |
Outcome results
Primary
Primary Patency of the Treated Renal Artery
Based on ultrasound images assessed by core lab.
Time frame: 9 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Formula™ Balloon-Expandable Renal Stent | Primary Patency of the Treated Renal Artery | 91 Lesions |
Comparison: Alternative hypothesis is 9-month primary patency rate greater than 60%.p-value: <0.000195% CI: [84.2, 95.9]Z-test, 1-sided
Secondary
30-day Clinical Success
\< 30% residual stenosis post-procedure by core lab analysis and no Major Adverse Events within 30 days.
Time frame: 30 Days
Population: 1 participant was lost to follow-up, 1 participant withdrew, 1 participant did not have core lab assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Formula™ Balloon-Expandable Renal Stent | 30-day Clinical Success | 95 Percentage of Participants |
Secondary
Acute Procedural Success
\< 30% residual stenosis post-procedure by core lab analysis and no Major Adverse Events before discharge.
Time frame: Prior to Discharge
Population: 1 participant did not have core lab assessment for stenosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Formula™ Balloon-Expandable Renal Stent | Acute Procedural Success | 95 Percentage of Participants |
Secondary
Number of Participants With 30-day Major Adverse Events
Clinical Events Committee Adjudicated Death, Clinical Events Committee Adjudicated Q-wave MI, Clinically-driven Target Lesion Revascularization, Clinical Events Committee Adjudicated Significant Embolic Events.
Time frame: 30 Days
Population: 1 participant withdrew and 1 participant was lost to follow-up prior to 30 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Formula™ Balloon-Expandable Renal Stent | Number of Participants With 30-day Major Adverse Events | 0 Participants |
Secondary
Number of Participants With 9-month Major Adverse Events
Clinical Events Committee Adjudicated Death, Clinical Events Committee Adjudicated Q-wave MI, Clinically-driven Target Lesion Revascularization, Clinical Events Committee Adjudicated Significant Embolic Events.
Time frame: 9 Months
Population: 3 participants withdrew, 4 died, and 1 was lost to follow-up prior to 300 days.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Formula™ Balloon-Expandable Renal Stent | Number of Participants With 9-month Major Adverse Events | Clinically-driven Target Lesion Revascularization | 2 Participants |
| Formula™ Balloon-Expandable Renal Stent | Number of Participants With 9-month Major Adverse Events | Clinical Events Committee (CEC) Adjudicated Death | 0 Participants |
| Formula™ Balloon-Expandable Renal Stent | Number of Participants With 9-month Major Adverse Events | CEC Adjudicated Significant Embolic Events | 0 Participants |
| Formula™ Balloon-Expandable Renal Stent | Number of Participants With 9-month Major Adverse Events | Clinical Events Committee Adjudicated Q-wave MI | 0 Participants |
Secondary
Technical Success
Successful delivery and deployment of a Formula™ Balloon-Expandable Stent at index procedure.
Time frame: Prior to Discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Formula™ Balloon-Expandable Renal Stent | Technical Success | 97 Percentage of Participants |