Clinical Trial: The HERCULES Trial - A Safety and Effectiveness Study of the Herculink Elite Renal Stent to Treat Renal Artery Stenosis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Clinical Trial to Assess the Safety and Efficacy of the RX Herculink(R) Elite(TM) Renal Stent System for the Treatment of Suboptimal Post-procedural Percutaneous Transluminal Angioplasty (PTA) in de
Brief Summary:
The purpose of this study is to determine whether the Herculink Elite Renal Stent System is safe and effective in the treatment of renal artery stenosis in patients with less than optimal angioplasty results and uncontrolled hypertension.
CAUTION: The Herculink Elite Renal Stent System Is An Investigational Device. Limited by Federal (U.S.) Law to Investigational Use Only.
Detailed Summary:
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.
CAUTION: The Herculink Elite Renal Stent System Is An Investigational Device. Limited by Federal (U.S.) Law to Investigational Use Only.
Sponsor: Abbott Vascular
Current Primary Outcome: Binary Restenosis Rate [ Time Frame: 9 months ]
Original Primary Outcome: Binary restenosis rate as determined by duplex ultrasound [ Time Frame: Nine months ]
Current Secondary Outcome:
- Death for Any Reason [ Time Frame: 30 days ]
- Ipsilateral Nephrectomy [ Time Frame: 30 days ]Ipsilateral: Situated on or affecting the same side as treated. Nephrectomy: Removal of the affected kidney
- Embolic Events Resulting in Kidney Damage [ Time Frame: 30 days ]Percentage of participants with an embolic event resulting in kidney damage.
- Event Free Rate of Clinically Indicated Target Lesion Revascularization (TLR) [ Time Frame: 9 months ]Event Free percentage: Defined as percentage of participants free from this event.
- 9 Month Blood Pressure (Systolic) [ Time Frame: Baseline (Pre-Procedure) and 9 months ]As compared to baseline (pre-procedure). Blood pressure measurements at 9 months.
- 9 Month Blood Pressure (Diastolic) [ Time Frame: 9 months and baseline ]As compared to baseline. See Population description.
- Acute Device Success [ Time Frame: 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.
- Acute Procedure Success [ Time Frame: 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.
- Acute Clinical Success [ Time Frame: 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.
- Primary Patency [ Time Frame: 9 months ]
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.
- Secondary Patency Rate of <60% Stenosis of the Target Lesion [ Time Frame: 9 months ]
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.
- 9 Month Anti-hypertensive Medication In-take, 1 Medication [ Time Frame: 9 months ]
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.
- 9 Month Anti-hypertensive Medication In-take, 2 Medications [ Time Frame: 9 months ]
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.
- 9 Month Anti-hypertensive Medication In-take, 3 Medications [ Time Frame: 9 months ]
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.
- 9 mo in Anti-hypertensive Medication In-take, ≥ 4 Medications [ Time Frame: 9 months ]
Number of Anti-Hyp
Original Secondary Outcome:
Information By: Abbott Vascular
Dates:
Date Received: June 21, 2007
Date Started: August 2007
Date Completion:
Last Updated: December 13, 2012
Last Verified: December 2012
