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The HERCULES Trial - A Safety and Effectiveness Study of the Herculink Elite Renal Stent to Treat Renal Artery Stenosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT00490841
First received: June 21, 2007
Last updated: December 13, 2012
Last verified: December 2012
History of Changes
Results First Received: September 6, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Renal Artery Obstruction
Hypertension, Renal
Intervention: Device: Herculink Elite Renal Stent System

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    RX Herculink Elite  
STARTED     202  
COMPLETED     189  
NOT COMPLETED     13  
Death                 5  
Withdrawal by Subject                 4  
Lost to Follow-up                 1  
30 day f/u, only non-study stent used                 3  



  Baseline Characteristics
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Reporting Groups
  Description
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.

Baseline Measures
    RX Herculink Elite  
Number of Participants  
[units: participants]
 		  202  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     39  
>=65 years     163  
Age  
[units: years]
Mean ± Standard Deviation 		  72.1  ± 9.4  
Gender  
[units: participants]
 		 
Female     126  
Male     76  
Region of Enrollment  
[units: participants]
 		 
United States     202  



  Outcome Measures
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1.  Primary:   Binary Restenosis Rate   [ Time Frame: 9 months ]
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2.  Secondary:   Death for Any Reason   [ Time Frame: 30 days ]
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3.  Secondary:   Ipsilateral Nephrectomy   [ Time Frame: 30 days ]
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4.  Secondary:   Embolic Events Resulting in Kidney Damage   [ Time Frame: 30 days ]
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5.  Secondary:   Event Free Rate of Clinically Indicated Target Lesion Revascularization (TLR)   [ Time Frame: 9 months ]
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6.  Secondary:   9 Month Blood Pressure (Systolic)   [ Time Frame: Baseline (Pre-Procedure) and 9 months ]
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7.  Secondary:   9 Month Blood Pressure (Diastolic)   [ Time Frame: 9 months and baseline ]
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8.  Secondary:   Acute Device Success   [ Time Frame: From beginning of index procedure to end of index proceedure. ]
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Measure Type Secondary
Measure Title Acute Device Success
Measure Description 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.
Time Frame From beginning of index procedure to end of index proceedure.  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Measured Values
    RX Herculink Elite  
Number of Participants Analyzed  
[units: participants]
 		  202  
Number of Devices Analyzed  
[units: Devices]
 		  247  
Acute Device Success  
[units: percentage of devices]
Number ( 95% Confidence Interval ) 		  96.0  
  ( 92.7 to 98.0 )  

No statistical analysis provided for Acute Device Success



9.  Secondary:   Acute Procedure Success   [ Time Frame: From beginning of index proceedure to end of index proceedure. ]
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10.  Secondary:   Acute Clinical Success   [ Time Frame: From beginning of index proceedure to end of index proceedure. ]
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11.  Secondary:   Primary Patency   [ Time Frame: 9 months ]
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12.  Secondary:   Secondary Patency Rate of <60% Stenosis of the Target Lesion   [ Time Frame: 9 months ]
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13.  Secondary:   9 Month Anti-hypertensive Medication In-take, 1 Medication   [ Time Frame: 9 months ]
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14.  Secondary:   9 Month Anti-hypertensive Medication In-take, 2 Medications   [ Time Frame: 9 months ]
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15.  Secondary:   9 Month Anti-hypertensive Medication In-take, 3 Medications   [ Time Frame: 9 months ]
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16.  Secondary:   9 mo in Anti-hypertensive Medication In-take, ≥ 4 Medications   [ Time Frame: 9 months ]
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17.  Secondary:   Renal Function (Measured by sCr)   [ Time Frame: 9 months ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Ellen Travis
Organization: Abbott Vascular
phone: 408-845-1512
e-mail: Ellen.Travis@av.abbott.com


No publications provided by Abbott Vascular

Publications automatically indexed to this study:


Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT00490841     History of Changes
Other Study ID Numbers: 05-102
Study First Received: June 21, 2007
Results First Received: September 6, 2011
Last Updated: December 13, 2012
Health Authority: United States: Food and Drug Administration