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

NCT00561457 | Completed Results

• 1 other identifier: BPV-1021
• Study Type: interventional
• Target: 134
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Iliac Artery Occlusive Disease

Keywords

Iliac; Artery; Occlusive; Stenosis

Outcome Measures

Primary Outcomes (1)

• Rate of Major Adverse Clinical Events (MACE)

  Major Adverse Clinical Events defined as peri-procedural death (death during the procedure or prior to hospital discharge), target lesion revascularization (TLR), or stented segment restenosis (\> 50%) at nine months postprocedure.

  9-months

Study Arms (1)

Iliac Stenting

EXPERIMENTAL

Stent placement in the iliac artery

Device: Bard Luminexx Iliac Stent and Delivery System

Interventions

Bard Luminexx Iliac Stent and Delivery System DEVICE

Iliac Stenting

Iliac Stenting

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• C. R. Bard: lead

MeSH Terms

Conditions

Bites and Stings; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Director of Clinical Affairs
• Organization: Bard Peripheral Vascular

John.Reviere@crbard.com

480-303-2644

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: November 20, 2007
• First Posted: November 21, 2007
• Study Start: June 1, 2003
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: March 1, 2017
• Results First Posted: May 4, 2011

Record last verified: 2017-01