The HERCULES Trial - A Safety and Effectiveness Study of... | NCT00490841

NCT00490841

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RX Herculink Elite	Experimental	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.	Device: Herculink Elite Renal Stent System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Herculink Elite Renal Stent System	Device	This is a prospective, non-randomized, single arm, multi-center study to evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in patients with sub-optimal renal PTA results in de novo or restenotic renal artery lesions. Patients who satisfy the inclusion/exclusion criteria will be enrolled at sites in the United States. Patients will have follow up visits for evaluation.

Outcomes Module

Measure	Description	Time Frame
Binary Restenosis Rate	Determined by duplex ultrasound or angiogram. Reported as the percentage of participants with occurance of binary restenosis.	9 months

Secondary Outcomes

Measure	Description	Time Frame
Death for Any Reason		30 days
Ipsilateral Nephrectomy	Ipsilateral: Situated on or affecting the same side as treated. Nephrectomy: Removal of the affected kidney	30 days

Eligibility Module

Eligibility Criteria

General Clinical Inclusion Criteria:

Subject is ≥18 years of age.
Subject and subject's physician agree to have the subject return for all required contact following study enrollment.
Subject has been informed of the nature of the study, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) of the respective clinical site.
Subject is a candidate for renal artery stenting.
Subject has uncontrolled systolic hypertension (systolic Blood Pressure[SBP] ≥140 mmHg), or uncontrolled diastolic hypertension (diastolic BP [DBP] ≥90 mmHg), or a combination of both in the presence of at least two (2) or more antihypertensive medications.
Subject has a baseline serum Creatinine of <2.5mg/dl

Angiographic Inclusion Criteria

Subject has either unilateral or bilateral de novo or restenotic after Percutaneous Transluminal Angioplasty (PTA) (in-stent restenosis excluded) atherosclerotic lesion(s). If bilateral lesions are to be treated, the most severe lesion must be successfully treated without complications before progressing to treat the second lesion. Treatment of bilateral lesions is to occur in the same procedural event.
Renal stenosis must be visually estimated to be ≥60% by angiography.
Subject has a suboptimal PTA result, defined as one of the following:
- ≥50% residual stenosis
- 10 mm Hg mean gradient or 20 mm Hg peak systolic gradient across the target lesion
- A flow-limiting dissection (NHLBI grade D) or TIMI flow <3
Renal stenosis must be visually estimated to be within 10 mm of the aortic renal border by angiography.
Target vessel reference diameter must be visually estimated to be ≥4mm and ≤7mm by angiography
Target lesion length must be visually estimated to be ≤15mm (including dissection) by angiography.
Expected ability to deliver the stent to the lesion (absence of excessive tortuosity or calcification).
Expected ability to fully expand the stent.

Clinical Exclusion Criteria

Subject has known hypersensitivity or contraindication to cobalt chromium or standard intraprocedure anticoagulant(s); subject has sensitivity to contrast which cannot be adequately pre-treated with medication.
Subject has known allergy or contraindication to clopidogrel (Plavix) or aspirin.
Subject has known bleeding disorder or hypercoagulable disorder, or will refuse blood transfusions.
Subject has suffered a gastrointestinal (GI) bleed within 30 days before the index procedure that would interfere with antiplatelet therapy.
Subject has renal insufficiency defined as serum Creatinine >2.5 mg/dl.
Subject has any immunosuppressive disorder, access site infection, or acute systemic infection due to any cause.
Subject has other medical illnesses (e.g., cancer, end-stage congestive heart failure) that may cause the subject to be non-compliant with protocol requirements, confound the data interpretation, or is associated with a life expectancy of less than three years.
Subject has any medical illnesses that would make them unlikely to respond to treatment (e.g., sickle cell nephropathy/sickle cell disease, scleroderma, arteriolar nephrosclerosis, hemolytic-uremic syndrome and vasculitis).
Subject has had a Q-wave MI within 30 days before index procedure.
Subject has had a stroke or TIA within 30 days before index procedure.
Subject has a history of congestive heart failure and has a previously documented LVEF ≤25%.
Subject is normotensive or has adequate control of hypertension (SBP <140 mmHg and DBP <90 mm Hg) utilizing diet control and/or medication regimen involving only one antihypertensive medication.
Subject has acute thrombophlebitis or deep vein thrombosis.
Subject is actively participating in another drug or device trial and has not completed the required protocol follow-up period. Subject may be enrolled only once in this study (Protocol # 05-102) and may not participate in any other clinical trial during the follow-up period.
Subject is unable to understand and cooperate with study procedures or provide informed consent.
Subject is unable to return for follow-up visits (distance, etc).
Subject is pregnant.
Subject has undergone vascular surgery (CABG, AAA repair, AF bypass) and has not fully recovered from the effects of surgery (<3 months).
Subject has planned staged treatment of bilateral renal artery stenosis.
Subject has had prior surgical intervention to the target artery, or has undergone previous stent placement in the target lesion.
Target lesion is located in a transplanted kidney.
Kidney to be treated is <8 cm as determined by duplex ultrasound report, CTA report, or MRA report within 180 days before procedure. If kidney size is documented by more than one method, e.g. CTA and ultrasound, and one of the methods is duplex ultrasound, the kidney size as documented by duplex ultrasound shall be used to determine study eligibility.
Subject has planned additional ancillary procedure(s) during renal stenting procedure.

Angiographic Exclusion Criteria

Subject has a lesion segment, including dissection, >15 mm in length.
Requirement for >1 stent to treat full length of lesion and dissection.
Target lesion has a total (100%) occlusion.
Evidence of thrombus or mobile filling defect in the target lesion or vessel.
Subject has co-existing aneurysmal or occlusive disease of the abdominal aorta requiring surgical reconstruction during the follow-up period.
Target lesion is non-atherosclerotic (fibromuscular dysplasia).
Subject artery has patent bifurcation within 10 mm of ostium that might be covered by placement of a stent.
The target lesion is within the artery of a solitary functioning kidney or, the subject has a contralateral totally occluded renal artery.
For planned treatment of bilateral lesions: the more critical lesion, i.e. lesion with the greater stenosis (which should be treated first), is either treated unsuccessfully or requires a bailout procedure. (NOTE: Less critical lesion is excluded at this point.)
Subject has any condition that precludes proper angiographic assessment or makes percutaneous arterial access unsafe.
The target lesion is densely calcified and will not yield during balloon dilation.
Subject has had recent change in renal function after unrelated catheter or surgical procedure with the clinical stigmata of atheroemboli syndrome (i.e., livedo reticularis: non-occlusive mesenteric ischemia; digital gangrene; progressive renal insufficiency without other identifiable etiology).
Subject has an accessory renal artery that has >50% stenosis. Accessory renal arteries may not be stented as part of this study.

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
Mark Bates, MD	CAMC Health System	Study Director
Stephen Textor, MD	Mayo Clinic	Study Director
Michael Jaff, DO	Vascular Diagnostic Laboratory	Study Director
Timothy Sullivan, MD	Heart Hospital of SD	Study Director
Andrew Blum, MD	Midwest Heart Foundation	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Abbott Vascular		Santa Clara	California	95054	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22511402	Derived	Jaff MR, Bates M, Sullivan T, Popma J, Gao X, Zaugg M, Verta P; HERCULES Investigators. Significant reduction in systolic blood pressure following renal artery stenting in patients with uncontrolled hypertension: results from the HERCULES trial. Catheter Cardiovasc Interv. 2012 Sep 1;80(3):343-50. doi: 10.1002/ccd.24449. Epub 2012 Jun 27.

IPD Sharing Statement Module

No data available

No data is available for this block.

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.

Arm/Group Information

ID	Title	Description
FG000	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.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG000202 subjects
COMPLETED		FG000189 subjects
NOT COMPLETED		FG00013 subjects

Type	Comment	Reasons
Death		FG0005 subjects
Withdrawal by Subject		FG0004 subjects
Lost to Follow-up		FG0001 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Binary Restenosis Rate

Determined by duplex ultrasound or angiogram. Reported as the percentage of participants with occurance of binary restenosis.

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.

Posted

Number

95% Confidence Interval

Percentage of lesions

9 months

Lesions

Participants

ID	Title	Description
OG000	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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Hematoma	Injury, poisoning and procedural complications	Abbott Categories	Systematic Assessment	Access site complication

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Bleeding	Surgical and medical procedures	Abbott Categories	Systematic Assessment	Access Site Complication

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Ellen Travis	Abbott Vascular	408-845-1512		Ellen.Travis@av.abbott.com

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

ID	Term
D012078	Renal Artery Obstruction
D006977	Hypertension, Renal

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Intervention Browse Module

No data available

No data is available for this block.

Masking Info