N/A N=134 Treatment

A Clinical Evaluation of the Bard® Luminexx™ Iliac Stent and Delivery System

Iliac Artery Occlusive Disease

Bottom Line

View on ClinicalTrials.gov: NCT00561457 ↗

Enrolled (actual)

134

Serious AEs

42.5%

Results posted

May 2011

Primary outcome: Primary: Rate of Major Adverse Clinical Events (MACE) — 0.153 MACE events per 9 months

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Bard Luminexx Iliac Stent and Delivery System (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: C. R. Bard
Primary completion: Jan 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Rate of Major Adverse Clinical Events (MACE)	0.153	—

Summary

To determine the safety and effectiveness of the LUMINEXX stent for the proposed indication of treatment of common and/or external iliac artery occlusive disease

Eligibility Criteria

Inclusion Criteria

Patient or legal guardian understands procedure and provides written informed consent prior to study participation.
Patient must be able and willing to comply with all study procedures including scheduled follow-up visits and diagnostic tests.
Lesion(s) distinctly localized in the common and/or external iliac arteries.
Reference lumen diameter (RLD) 6 mm and 9 mm.
Stenosis 30% and symptomatic ischemic disease (Category 1-6 Chronic Limb Ischemia or Threatened or Irreversible Acute Limb Ischemia).

Exclusion Criteria

Patients diagnosed with preoperative coagulation disorder or with contraindications to antiplatelet or anticoagulant therapy.
Patients who are pregnant or planning to become pregnant during the clinical investigation.
Patients with a life expectancy < 3 years.
Patients currently or scheduled to be enrolled in another investigation that conflicts with follow-up testing or may confound the study data.
Patients with absolute contraindication to x-ray contrast media or medications normally administered during an interventional procedure.
Patients with severe tortuosity or angulation of a vessel that may prevent access in the opinion of the investigator.
The presence of soft, thrombotic or embolic material within or adjacent to the lesion(s) being treated with the study device, in the opinion of the investigator.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00561457). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.