Safety and Effectiveness Study of the HERCULINK 14 Stent to Treat Renal Artery Disease

Renal Artery Obstruction Clinical Trial

— HERCULINK 14  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00180544
• Other study ID #: 99-707
• Status: Terminated
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: July 24, 2008
• Start date: July 2000
• Est. completion date: August 2004

Study information

• Verified date: July 2008
• Source: Abbott Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 167
• Est. completion date: August 2004
• Est. primary completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Artery Obstruction

Intervention

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.

Locations

Country	Name	City	State
United States	Alton Ochsner Medical Foundation	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Vascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary patency .		at 9-months	Yes
Secondary	Acute procedural success		Acute	No
Secondary	Access site events requiring surgical repair or intervention		Acute	Yes
Secondary	Major adverse events (e.g. death, nephrectomy, target lesion revascularization (TLR)		at 30 days	Yes
Secondary	TLR		at 9 months	Yes
Secondary	Renal function		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.	Yes
Secondary	Changes in blood pressure		9 months	Yes