Safety and Effectiveness Study of the HERCULINK 14 Stent to Treat Renal Artery Disease - Full Text View

Purpose

The purpose of this study is to evaluate the safety and effectiveness of the RX HERCULINK 14 Peripheral Stent System in treating atherosclerotic renal artery stenosis.

Condition	Intervention	Phase
Renal Artery Obstruction	Device: Stenting: Renal Artery	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment

Official Title:	A Prospective, Non-Randomized, Multicenter, Single-Arm, Clinical Trial to Assess the Safety and Efficacy of the RX HERCULINK 14 Peripheral Stent System for Treatment in de Novo or Restenotic Renal Artery Stenosis

Further study details as provided by Abbott Vascular:

Primary Outcome Measures:

Primary patency . [ Time Frame: at 9-months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Acute procedural success [ Time Frame: Acute ] [ Designated as safety issue: No ]
Access site events requiring surgical repair or intervention [ Time Frame: Acute ] [ Designated as safety issue: Yes ]
Major adverse events (e.g. death, nephrectomy, target lesion revascularization (TLR) [ Time Frame: at 30 days ] [ Designated as safety issue: Yes ]
TLR [ Time Frame: at 9 months ] [ Designated as safety issue: Yes ]
Renal function [ Time Frame: measured at 1, 6, 9, and 12-month follow-up, and every three months thereafter until approximately May 2003 or until patient 169 completes 12 month follow-up. ] [ Designated as safety issue: Yes ]
Changes in blood pressure [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Enrollment:	167
Study Start Date:	July 2000
Study Completion Date:	August 2004
Primary Completion Date:	August 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Male and female patients, who meet study eligibility criteria, agree to participate in the trial, and sign an informed consent, will be enrolled in the study. A HERCULINK™ 14 Peripheral Stent will be used in the treatment of suboptimal post- procedural percutaneous transluminal angioplasty (PTA) atherosclerotic renal artery stenoses.	Device: Stenting: Renal Artery Male and female patients, who meet study eligibility criteria, agree to participate in the trial, and sign an informed consent, will be enrolled in the study. A HERCULINK™ 14 Peripheral Stent will be used in the treatment of suboptimal post- procedural percutaneous transluminal angioplasty (PTA) atherosclerotic renal artery stenoses.

Detailed Description:

A prospective, non-randomized, multi-center, single-arm clinical trial to evaluate the safety and efficacy of the RX HERCULINK™ 14 Peripheral Stent System in the treatment of suboptimal post- procedural percutaneous transluminal angioplasty (PTA) results in de novo or restenotic atherosclerotic renal artery stenoses.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of renal artery atherosclerosis; candidate for renal artery angioplasty and stenting; blood pressure >160/90

Exclusion Criteria:

Totally occluded renal artery on the opposite side; only one functioning kidney; target lesion is in a transplanted kidney; renal insufficiency

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00180544

Locations


United States, Louisiana
	Alton Ochsner Medical Foundation
	New Orleans, Louisiana, United States, 70121

Sponsors and Collaborators

Abbott Vascular

Investigators


Principal Investigator:	Stephen Ramee, M.D.	Alton Ochsner Medical Foundation

More Information

Responsible Party:	Abbott Vascular ( Maureen Kennedy )
Study ID Numbers:	99-707
First Received:	September 13, 2005
Last Updated:	July 24, 2008
ClinicalTrials.gov Identifier:	NCT00180544
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Arterial Occlusive Diseases

Renal artery stenosis

Urologic Diseases

Vascular Diseases

Constriction, Pathologic

Kidney Diseases

Renal Artery Obstruction

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 27, 2008

Sponsored by:	Abbott Vascular
Information provided by:	Abbott Vascular
ClinicalTrials.gov Identifier:	NCT00180544