Trial Outcomes & Findings for The HERCULES Trial - A Safety and Effectiveness Study of the Herculink Elite Renal Stent to Treat Renal Artery Stenosis (NCT NCT00490841)
NCT ID: NCT00490841
Last Updated: 2012-12-18
Results Overview
Determined by duplex ultrasound or angiogram. Reported as the percentage of participants with occurance of binary restenosis.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
202 participants
Primary outcome timeframe
9 months
Results posted on
2012-12-18
Participant Flow
All subjects admitted for percutaneous renal artery revascularization were considered for enrollment at sites throughout the USA. Dates of enrollment: August 31, 2007 through October 02, 2009.
Subjects required to have documented uncontrolled hypertension (SBP at least 140 mmHg or DBP at least 90 mmHg, or both) in the presence of at least two (2) or more antihypertensive medications, all clinical eligibility criteria had to have been met and sujects had to sign the informed consent form. Intent to treat (ITT) population.
Participant milestones
| Measure |
RX Herculink Elite
To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
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|---|---|
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Overall Study
STARTED
|
202
|
|
Overall Study
COMPLETED
|
189
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
RX Herculink Elite
To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
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|---|---|
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Overall Study
Death
|
5
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
30 day f/u, only non-study stent used
|
3
|
Baseline Characteristics
The HERCULES Trial - A Safety and Effectiveness Study of the Herculink Elite Renal Stent to Treat Renal Artery Stenosis
Baseline characteristics by cohort
| Measure |
RX Herculink Elite
n=202 Participants
To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
163 Participants
n=5 Participants
|
|
Age Continuous
|
72.1 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
126 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
202 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 9 monthsPopulation: Subject total reflects those who were evaluable at the time of analysis. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician. Only a certain number of patients were required to have angiographic follow-up to provide this endpoint information.
Determined by duplex ultrasound or angiogram. Reported as the percentage of participants with occurance of binary restenosis.
Outcome measures
| Measure |
RX Herculink Elite
n=209 Lesions
To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
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|---|---|
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Binary Restenosis Rate
|
10.5 Percentage of lesions
Interval to 14.7
One-sided confidence interval was computed for this endpoint, lower bound is not provided.
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SECONDARY outcome
Timeframe: 30 daysPopulation: Non-Hierarchical Subject Counts, Per Subject Analysis (Intent-to-Treat Population). The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
Outcome measures
| Measure |
RX Herculink Elite
n=201 Participants
To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
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|---|---|
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Death for Any Reason
|
0.5 percentage of participants
Interval 0.0 to 2.7
|
SECONDARY outcome
Timeframe: 30 daysPopulation: intention to treat (ITT). The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
Ipsilateral: Situated on or affecting the same side as treated. Nephrectomy: Removal of the affected kidney
Outcome measures
| Measure |
RX Herculink Elite
n=201 Participants
To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
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|---|---|
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Ipsilateral Nephrectomy
|
0 percentage of participants
Interval 0.0 to 1.8
|
SECONDARY outcome
Timeframe: 30 daysPopulation: The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
Percentage of participants with an embolic event resulting in kidney damage.
Outcome measures
| Measure |
RX Herculink Elite
n=201 Participants
To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
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|---|---|
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Embolic Events Resulting in Kidney Damage
|
1.0 Percentage of participants
Interval 0.1 to 3.5
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SECONDARY outcome
Timeframe: 9 monthsPopulation: The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
Event Free percentage: Defined as percentage of participants free from this event.
Outcome measures
| Measure |
RX Herculink Elite
n=201 Participants
To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
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|---|---|
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Event Free Rate of Clinically Indicated Target Lesion Revascularization (TLR)
|
96.9 Event Free Percentage
|
SECONDARY outcome
Timeframe: Baseline (Pre-Procedure) and 9 monthsPopulation: The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
As compared to baseline (pre-procedure). Blood pressure measurements at 9 months.
Outcome measures
| Measure |
RX Herculink Elite
n=173 Participants
To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
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|---|---|
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9 Month Blood Pressure (Systolic)
9 month Systolic Blood Pressure
|
145.3 mmHg
Interval 142.1 to 148.5
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9 Month Blood Pressure (Systolic)
Baseline (Pre-Procedure) Systolic Blood Pressure
|
162.3 mmHg
Interval 159.8 to 164.9
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SECONDARY outcome
Timeframe: 9 months and baselinePopulation: The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
As compared to baseline. See Population description.
Outcome measures
| Measure |
RX Herculink Elite
n=173 Participants
To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
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|---|---|
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9 Month Blood Pressure (Diastolic)
9 month Diastolic Blood Pressure
|
75.4 mmHg
Interval 73.6 to 77.1
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9 Month Blood Pressure (Diastolic)
Baseline Diastolic Blood Pressure
|
77.7 mmHg
Interval 76.1 to 79.3
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SECONDARY outcome
Timeframe: From beginning of index procedure to end of index proceedure.Acute device success is defined as, on a per device basis, the achievement of successful delivery of the assigned device(s)as intended to the designated location.
Outcome measures
| Measure |
RX Herculink Elite
n=247 Devices
To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
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|---|---|
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Acute Device Success
|
96.0 percentage of devices
Interval 92.7 to 98.0
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SECONDARY outcome
Timeframe: From beginning of index proceedure to end of index proceedure.Attainment of a final result of \< 30% residual stenosis, as determined by the Angiographic Core Lab.
Outcome measures
| Measure |
RX Herculink Elite
n=240 Lesions
To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
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|---|---|
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Acute Procedure Success
|
99.2 percentage of participants
Interval 97.0 to 99.9
|
SECONDARY outcome
Timeframe: From beginning of index proceedure to end of index proceedure.Procedure success without Major Adverse Events (MAE)or access site event requiring surgical or percutaneous intervention prior to hospital discharge. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
Outcome measures
| Measure |
RX Herculink Elite
n=201 Participants
To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
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|---|---|
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Acute Clinical Success
|
98 percentage of participants
Interval 95.0 to 99.5
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SECONDARY outcome
Timeframe: 9 monthsPopulation: Subject total reflects those who were evaluable at the time of analysis.
Defined as \<60% stenosis without prior re-intervention, as determined by duplex ultrasound or angiogram. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
Outcome measures
| Measure |
RX Herculink Elite
n=209 Lesions
To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
|
|---|---|
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Primary Patency
|
88 percentage of participants
Interval 82.9 to 92.1
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: Subject total reflects those who were evaluable at the time of analysis.
As determined by duplex ultrasound or angiography regardless of PTA, stenting, or bypass since index procedure. Rate reported as a percentage of participants with this condition. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
Outcome measures
| Measure |
RX Herculink Elite
n=208 Lesions
To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
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|---|---|
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Secondary Patency Rate of <60% Stenosis of the Target Lesion
|
95.2 percentage of participants
Interval 91.3 to 97.7
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: Patients with baseline Anti-Hypertensive medication intake equal to 1 medication: 0.5%
Number of Anti-Hypertensive Medications taken-baseline compared to follow up, Per Subject Analysis (Intent-to-Treat Population), reported as the percentage of participants using the number of medications indicated. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
Outcome measures
| Measure |
RX Herculink Elite
n=174 Participants
To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
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|---|---|
|
9 Month Anti-hypertensive Medication In-take, 1 Medication
|
4.6 percentage of participants
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: Patients with baseline Anti-Hypertensive medication intake equal to 2 medications: 29.2%
Number of Anti-Hypertensive Medications taken-baseline compared to follow up, Per Subject Analysis (Intent-to-Treat Population)), reported as the percentage of participants using the number of medications indicated. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
Outcome measures
| Measure |
RX Herculink Elite
n=174 Participants
To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
|
|---|---|
|
9 Month Anti-hypertensive Medication In-take, 2 Medications
|
29.3 percentage of participants
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: Patients with baseline Anti-Hypertensive medication intake equal to 3 Medications: 30.7%
Number of Anti-Hypertensive Medications taken-baseline compared to follow up, Per Subject Analysis (Intent-to-Treat Population)), reported as the percentage of participants using the number of medications indicated. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
Outcome measures
| Measure |
RX Herculink Elite
n=174 Participants
To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
|
|---|---|
|
9 Month Anti-hypertensive Medication In-take, 3 Medications
|
28.2 percentage of participants
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: Patients with baseline Anti-Hypertensive medication intake equal to or greater than 4 Medications: 39.6%
Number of Anti-Hypertensive Medications taken at follow up compared to baseline, Per Subject Analysis (Intent-to-Treat Population)), reported as the percentage of participants using the number of medications indicated. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
Outcome measures
| Measure |
RX Herculink Elite
n=174 Participants
To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
|
|---|---|
|
9 mo in Anti-hypertensive Medication In-take, ≥ 4 Medications
|
37.4 percentage of participants
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: Subject total reflects those who were evaluable at the time of analysis.
sCR= Serum Creatinine, per subject analysis. ITT. Renal function (measured by sCr) @ baseline: 1.2mg/dL (1.2, 1.3). The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
Outcome measures
| Measure |
RX Herculink Elite
n=167 Participants
To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
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|---|---|
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Renal Function (Measured by sCr)
|
1.3 mg/dL
95% Confidence Interval 0.6 • Interval 1.2 to 1.4
|
Adverse Events
RX Herculink Elite
Serious events: 83 serious events
Other events: 145 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RX Herculink Elite
n=199 participants at risk
To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
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|---|---|
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Injury, poisoning and procedural complications
Hematoma
|
0.50%
1/199 • Number of events 1 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Surgical and medical procedures
Pseudoaneurysm
|
0.50%
1/199 • Number of events 1 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Blood and lymphatic system disorders
Blood Dyscrasia
|
3.0%
6/199 • Number of events 6 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
4.0%
8/199 • Number of events 8 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
2.5%
5/199 • Number of events 6 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Cardiac disorders
Angina
|
2.5%
5/199 • Number of events 5 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Cardiac disorders
Arrhythmias (Bradycardia & Tachycardia)
|
4.5%
9/199 • Number of events 11 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Cardiac disorders
Cardiac Arrest
|
0.50%
1/199 • Number of events 1 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Cardiac disorders
Cardiomyopathy
|
0.50%
1/199 • Number of events 1 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Cardiac disorders
Chest Pain
|
1.0%
2/199 • Number of events 2 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Cardiac disorders
Congestive Heart Failure
|
3.5%
7/199 • Number of events 7 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Cardiac disorders
Hypertension Exacerbation
|
3.5%
7/199 • Number of events 8 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Cardiac disorders
Hypotension
|
1.0%
2/199 • Number of events 2 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Cardiac disorders
Pacemaker Issue
|
0.50%
1/199 • Number of events 1 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Cardiac disorders
Unstable Angina
|
3.0%
6/199 • Number of events 7 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Gastrointestinal disorders
Appendicitis
|
0.50%
1/199 • Number of events 1 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Gastrointestinal disorders
Diarrhea
|
1.0%
2/199 • Number of events 2 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Gastrointestinal disorders
Digestive Disorder
|
2.0%
4/199 • Number of events 4 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Gastrointestinal disorders
Diverticulitis
|
0.50%
1/199 • Number of events 1 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Gastrointestinal disorders
Nausea
|
1.0%
2/199 • Number of events 2 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Gastrointestinal disorders
Pyloric Channel Ulcer
|
1.0%
2/199 • Number of events 2 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Gastrointestinal disorders
Vomiting
|
1.0%
2/199 • Number of events 2 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Infections and infestations
Joint/Bone
|
1.0%
2/199 • Number of events 3 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Infections and infestations
Urinary Tract Infection
|
0.50%
1/199 • Number of events 1 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Infections and infestations
Viral, Bacterial and Fungal Infections
|
2.0%
4/199 • Number of events 4 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance
|
3.0%
6/199 • Number of events 6 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
General disorders
Back Pain
|
1.0%
2/199 • Number of events 2 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
General disorders
Edema (Non Pulmonary)
|
0.50%
1/199 • Number of events 1 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
General disorders
Joint Pain
|
1.5%
3/199 • Number of events 3 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
General disorders
Joint/Bone
|
0.50%
1/199 • Number of events 1 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
General disorders
Lightheadedness/Dizziness
|
1.0%
2/199 • Number of events 2 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
General disorders
Medication Side Effect
|
0.50%
1/199 • Number of events 1 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
General disorders
Myalgia
|
0.50%
1/199 • Number of events 1 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
General disorders
Pain
|
0.50%
1/199 • Number of events 1 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
General disorders
Syncope
|
2.0%
4/199 • Number of events 4 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
General disorders
Trauma
|
1.5%
3/199 • Number of events 3 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
General disorders
Vision Disturbance
|
0.50%
1/199 • Number of events 1 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
General disorders
Weight Gain/Loss
|
0.50%
1/199 • Number of events 1 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Nervous system disorders
Neuropathy
|
0.50%
1/199 • Number of events 1 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Nervous system disorders
Stroke/Cerebral Vascular Accident
|
2.0%
4/199 • Number of events 4 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Nervous system disorders
Transient Ischemic Attack
|
0.50%
1/199 • Number of events 1 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Blood and lymphatic system disorders
GI Bleed
|
2.5%
5/199 • Number of events 5 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Blood and lymphatic system disorders
Retroperitoneal Bleed
|
1.0%
2/199 • Number of events 2 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.50%
1/199 • Number of events 1 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
2.0%
4/199 • Number of events 4 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.0%
4/199 • Number of events 4 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
0.50%
1/199 • Number of events 1 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.0%
2/199 • Number of events 2 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.50%
1/199 • Number of events 1 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
1.5%
3/199 • Number of events 3 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Renal and urinary disorders
Creatinine Increase
|
1.0%
2/199 • Number of events 2 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Renal and urinary disorders
Cysts/Stones
|
0.50%
1/199 • Number of events 1 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Renal and urinary disorders
Insufficiency
|
2.0%
4/199 • Number of events 4 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Renal and urinary disorders
Renal Failure
|
1.0%
2/199 • Number of events 3 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Vascular disorders
Claudication
|
1.0%
2/199 • Number of events 2 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Vascular disorders
Ischemia
|
0.50%
1/199 • Number of events 1 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Vascular disorders
Restenosis
|
7.5%
15/199 • Number of events 16 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Vascular disorders
Stenosis
|
8.0%
16/199 • Number of events 21 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Vascular disorders
Thrombosis
|
1.0%
2/199 • Number of events 2 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Vascular disorders
Total Occlusion
|
1.0%
2/199 • Number of events 2 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
Other adverse events
| Measure |
RX Herculink Elite
n=199 participants at risk
To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
|
|---|---|
|
Surgical and medical procedures
Bleeding
|
6.0%
12/199 • Number of events 12 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Surgical and medical procedures
Hematoma
|
9.5%
19/199 • Number of events 20 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Cardiac disorders
Hypertention Exacerbation
|
13.6%
27/199 • Number of events 28 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Gastrointestinal disorders
Digestive Disorder
|
6.0%
12/199 • Number of events 12 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Gastrointestinal disorders
Nausea
|
7.0%
14/199 • Number of events 15 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
Infections and infestations
Urinary Tract Infection
|
6.0%
12/199 • Number of events 13 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
General disorders
Back Pain
|
11.1%
22/199 • Number of events 24 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
General disorders
Fatigue/Weakness
|
5.5%
11/199 • Number of events 12 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
General disorders
Joint Pain
|
5.5%
11/199 • Number of events 11 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
General disorders
Lightheadedness/Dizziness
|
7.5%
15/199 • Number of events 16 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
General disorders
Myalgia
|
5.5%
11/199 • Number of events 14 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
|
General disorders
Pain
|
6.5%
13/199 • Number of events 14 • Post-procedure through 312 days
Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60