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

NCT00490841 | Completed Results DMC

• 1 other identifier: 05-102
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Artery Obstruction; Hypertension, Renal

Outcome Measures

Primary Outcomes (1)

• Binary Restenosis Rate

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

  9 months

Secondary Outcomes (16)

• Death for Any Reason

  30 days

• Ipsilateral Nephrectomy

  30 days

• Embolic Events Resulting in Kidney Damage

  30 days

• Event Free Rate of Clinically Indicated Target Lesion Revascularization (TLR)

  9 months

• 9 Month Blood Pressure (Systolic)

  Baseline (Pre-Procedure) and 9 months

Study Arms (1)

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

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.

RX Herculink Elite

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Abbott Vascular

Santa Clara, California, 95054, United States

Location

Related Publications (1)

• 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.

  PMID: 22511402 DERIVED

MeSH Terms

Conditions

Renal Artery Obstruction; Hypertension, Renal

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Hypertension

Results Point of Contact

• Title: Ellen Travis
• Organization: Abbott Vascular

Ellen.Travis@av.abbott.com

408-845-1512

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2007
• First Posted: June 25, 2007
• Study Start: August 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: December 1, 2012
• Last Updated: December 18, 2012
• Results First Posted: January 30, 2012

Record last verified: 2012-12

Locations

US (1)