A Phase 3 interventional study of Stenting: Renal Artery in Renal Artery Obstruction, sponsored by Abbott Medical Devices. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-07-28.
Sponsored by Abbott Medical Devices · Phase 3, Interventional, and Treatment
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.
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.
57 studies on the registry are indexed under Renal Artery Obstruction; 8 are open to participants now.
This study's enrollment of 167 is above the median of 100 across 41 interventional studies indexed under Renal Artery Obstruction.
Browse Renal Artery Obstruction studies →Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Primary patency .
Time frame: at 9-months
Acute procedural success
Time frame: Acute
Access site events requiring surgical repair or intervention
Time frame: Acute
Major adverse events (e.g. death, nephrectomy, target lesion revascularization (TLR)
Time frame: at 30 days
TLR
Time frame: at 9 months
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.
Changes in blood pressure
Time frame: 9 months
This study is terminated, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.
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Abbott Medical Devices