Trial Outcomes & Findings for A Clinical Evaluation of the Bard® Luminexx™ Iliac Stent and Delivery System (NCT NCT00561457)
NCT ID: NCT00561457
Last Updated: 2017-03-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
134 participants
Primary outcome timeframe
9-months
Results posted on
2017-03-01
Participant Flow
Subject enrollment was completed November 1, 2004 with a total of 134 patients from 9 study sites.
Participant milestones
| Measure |
Luminexx Iliac Stent and Delivery System
Bard® LUMINEXX\* Iliac Stent and the Bard® LUMINEXX\* 6F Iliac Stent systems.
|
|---|---|
|
Overall Study
STARTED
|
134
|
|
Overall Study
COMPLETED
|
110
|
|
Overall Study
NOT COMPLETED
|
24
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Evaluation of the Bard® Luminexx™ Iliac Stent and Delivery System
Baseline characteristics by cohort
| Measure |
Luminexx Iliac Stent and Delivery System
n=134 Participants
Bard® LUMINEXX\* Iliac Stent and the Bard® LUMINEXX\* 6F Iliac Stent systems.
|
|---|---|
|
Age, Continuous
|
67.31 years
STANDARD_DEVIATION 10.31 • n=5 Participants
|
|
Gender
Female
|
61 Participants
n=5 Participants
|
|
Gender
Male
|
73 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
134 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 9-monthsPopulation: 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.
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.
Outcome measures
| Measure |
Luminexx Iliac Stent and Delivery System
n=110 Participants
Bard® LUMINEXX\* Iliac Stent and the Bard® LUMINEXX\* 6F Iliac Stent systems.
|
|---|---|
|
Rate of Major Adverse Clinical Events (MACE)
|
0.153 MACE events per 9 months
Interval 0.0905 to 0.2292
|
Adverse Events
Luminexx Iliac Stent and Delivery System
Serious events: 57 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Luminexx Iliac Stent and Delivery System
n=134 participants at risk
Bard® LUMINEXX\* Iliac Stent and the Bard® LUMINEXX\* 6F Iliac Stent systems.
|
|---|---|
|
Surgical and medical procedures
Distal Revascularization (Target Limb)
|
11.9%
16/134 • Number of events 25 • 2 years
|
|
Surgical and medical procedures
Revascularization (Non-target Limb)
|
9.7%
13/134 • Number of events 14 • 2 years
|
|
Vascular disorders
Bleeding
|
4.5%
6/134 • Number of events 6 • 2 years
|
|
Cardiac disorders
Angina/Coronary Ischemia
|
6.7%
9/134 • Number of events 9 • 2 years
|
|
Vascular disorders
Sepsis
|
4.5%
6/134 • Number of events 8 • 2 years
|
|
Vascular disorders
Arterial Thrombosis
|
3.7%
5/134 • Number of events 8 • 2 years
|
|
Surgical and medical procedures
Target Lesion Revascularization
|
1.5%
2/134 • Number of events 2 • 2 years
|
|
Injury, poisoning and procedural complications
False Aneurysm
|
3.0%
4/134 • Number of events 4 • 2 years
|
|
Surgical and medical procedures
Amputation on Study Side Limb
|
3.0%
4/134 • Number of events 4 • 2 years
|
|
Cardiac disorders
Arrhythmia
|
3.7%
5/134 • Number of events 8 • 2 years
|
|
Cardiac disorders
Sudden Cardiac Death
|
1.5%
2/134 • Number of events 2 • 2 years
|
|
Nervous system disorders
Stroke
|
3.0%
4/134 • Number of events 4 • 2 years
|
|
Cardiac disorders
Myocardial Infarction
|
3.0%
4/134 • Number of events 4 • 2 years
|
|
Nervous system disorders
Carotid Artery Disease
|
3.0%
4/134 • Number of events 4 • 2 years
|
|
Cardiac disorders
Congestive Heart Failure
|
2.2%
3/134 • Number of events 4 • 2 years
|
|
Vascular disorders
Hypertension
|
1.5%
2/134 • Number of events 2 • 2 years
|
|
Renal and urinary disorders
Renal Complications
|
1.5%
2/134 • Number of events 2 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.5%
2/134 • Number of events 2 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
1.5%
2/134 • Number of events 2 • 2 years
|
|
Vascular disorders
Arteriovenous Fistula
|
0.75%
1/134 • Number of events 2 • 2 years
|
|
Infections and infestations
Infection (non-sepsis)
|
1.5%
2/134 • Number of events 3 • 2 years
|
|
Vascular disorders
Claudication (Non-target limb)
|
2.2%
3/134 • Number of events 4 • 2 years
|
|
Vascular disorders
Claudication (Target Limb)
|
1.5%
2/134 • Number of events 2 • 2 years
|
|
Surgical and medical procedures
Dissection (Target Vessel)
|
0.75%
1/134 • Number of events 1 • 2 years
|
|
Vascular disorders
Critical Limb Ischemia
|
1.5%
2/134 • Number of events 2 • 2 years
|
|
Vascular disorders
Hypotension
|
0.75%
1/134 • Number of events 1 • 2 years
|
|
Vascular disorders
Aneurysm (Site Other)
|
0.75%
1/134 • Number of events 1 • 2 years
|
|
Nervous system disorders
Cerebrovascular Disease
|
0.75%
1/134 • Number of events 1 • 2 years
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.75%
1/134 • Number of events 1 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.75%
1/134 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.75%
1/134 • Number of events 1 • 2 years
|
|
General disorders
Fever
|
0.75%
1/134 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Hematuria
|
0.75%
1/134 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Ischemic Colitis
|
0.75%
1/134 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
1.5%
2/134 • Number of events 2 • 2 years
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.75%
1/134 • Number of events 1 • 2 years
|
|
Cardiac disorders
Myocardial Ischemia
|
0.75%
1/134 • Number of events 1 • 2 years
|
|
Reproductive system and breast disorders
Prostatic Hypertrophy
|
0.75%
1/134 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
1.5%
2/134 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Small Bowel Obstruction
|
0.75%
1/134 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Urinary Retention
|
0.75%
1/134 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Pancreatitis
|
0.75%
1/134 • Number of events 1 • 2 years
|
|
Cardiac disorders
Valvular Heart Disease
|
0.75%
1/134 • Number of events 1 • 2 years
|
|
Cardiac disorders
Cardiovascular Disease
|
0.75%
1/134 • Number of events 1 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Lung Cancer
|
0.75%
1/134 • Number of events 1 • 2 years
|
|
Vascular disorders
Arterial Perforation/Rupture
|
0.75%
1/134 • Number of events 1 • 2 years
|
|
Surgical and medical procedures
Revascularization Target Limb
|
0.75%
1/134 • Number of events 1 • 2 years
|
|
Infections and infestations
Upper Extremity Cellulitis
|
0.75%
1/134 • Number of events 1 • 2 years
|
Other adverse events
| Measure |
Luminexx Iliac Stent and Delivery System
n=134 participants at risk
Bard® LUMINEXX\* Iliac Stent and the Bard® LUMINEXX\* 6F Iliac Stent systems.
|
|---|---|
|
General disorders
Pain
|
4.5%
6/134 • Number of events 8 • 2 years
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
1.5%
2/134 • Number of events 2 • 2 years
|
|
Cardiac disorders
Angina/Coronary Ischemia
|
1.5%
2/134 • Number of events 2 • 2 years
|
|
Vascular disorders
Bleeding
|
1.5%
2/134 • Number of events 2 • 2 years
|
|
Renal and urinary disorders
Renal Complications
|
3.0%
4/134 • Number of events 5 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60