Iliac Artery Occlusive Disease
Conditions
Keywords
Iliac, Artery, Occlusive, Stenosis
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
Detailed description
The study is designed to collect safety and efficacy data on the Bard Luminexx Iliac Stent in a broad patient population having indications for iliac stenting. Effectiveness in this study will be demonstrated by the prevention of Major Adverse Clinical Events (MACE). The composite primary endpoint of this clinical trial is freedom from peri-procedural death and freedom from stented segment revascularization or restenosis (\>50%) at nine months.
Interventions
DEVICEBard Luminexx Iliac Stent and Delivery System
Iliac Stenting
Sponsors
C. R. Bard
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Major Adverse Clinical Events (MACE) | 9-months | 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. |
Participant flow
Recruitment details
Subject enrollment was completed November 1, 2004 with a total of 134 patients from 9 study sites.
Participants by arm
| Arm | Count |
|---|---|
| Luminexx Iliac Stent and Delivery System Bard® LUMINEXX\* Iliac Stent and the Bard® LUMINEXX\* 6F Iliac Stent systems. | 134 |
| Total | 134 |
Baseline characteristics
| Characteristic | Luminexx Iliac Stent and Delivery System |
|---|---|
| Age, Continuous | 67.31 years STANDARD_DEVIATION 10.31 |
| Gender Female | 61 Participants |
| Gender Male | 73 Participants |
| Region of Enrollment United States | 134 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 13 / 134 |
| serious Total, serious adverse events | 57 / 134 |
Outcome results
Primary
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.
Time frame: 9-months
Population: The analysis was an intention to treat (ITT)population which included the data for all completed patients (those who had a MACE event within 9-months and those who reached 9 months without experiencing an event). Natural censoring was used in the analysis according to the statistical analysis plan.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Luminexx Iliac Stent and Delivery System | Rate of Major Adverse Clinical Events (MACE) | 0.153 MACE events per 9 months |