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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00908947
Other study ID # BPV-08-001
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date February 2011
Est. completion date September 19, 2018

Study information

Verified date November 2019
Source C. R. Bard
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objectives of this study are to collect post-market confirmatory evidence of the safety and effectiveness of the Bard® LifeStent® Vascular Stent System and LifeStent® XL Vascular Stent System (together the "LifeStent® Vascular Stent System").


Description:

The study is a prospective, multi-center, single-arm, non-randomized study enrolling up to 234 subjects with lifestyle-limiting claudication or ischemic rest pain attributable to lesion(s) (stenosed, occluded, restenosed, or re-occluded) in the infra-inguinal segment (Superficial femoral artery [SFA] and/or proximal popliteal artery) that are amenable to treatment by percutaneous transluminal angioplasty (PTA) and stenting. All subjects enrolled in the study will receive PTA and stenting.


Recruitment information / eligibility

Status Terminated
Enrollment 173
Est. completion date September 19, 2018
Est. primary completion date September 18, 2018
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria:

1. The subject provides written informed consent using an Informed Consent Form (ICF) that is reviewed and approved by the Institutional Review Board (IRB) for the site.

2. Subject agrees to comply with the protocol-mandated follow-up procedures and visits.

3. The subject is = 21 years old.

4. Male or female subjects; female subjects of childbearing potential must have a negative urine pregnancy test at the time of screening.

5. The subject has lifestyle-limiting claudication or ischemic rest pain defined as: Rutherford Category 2-4.

6. The target lesion(s) has angiographic evidence of stenosis or restenosis = 50% or occlusion (by visual estimate) and is amenable to PTA with stenting.

7. The total target lesion(s) length must be = 240 mm.

8. The target vessel reference diameter is = 4.0 mm and = 6.5 mm (by visual estimate), and therefore appropriate for treatment with available stent diameters of 6.0 mm and 7.0 mm.

Exclusion Criteria:

1. The subject is unable or unwilling to provide informed consent, or is unable or unwilling to conform to the study protocol follow-up procedures and visits.

2. The subject has claudication or critical limb ischemia described as Rutherford Category 1 (mild claudication), 5 (minor tissue loss) or 6 (major tissue loss.

3. The subject has multiple stenoses or occlusions > 240 mm.

4. The subject has a previous stent or stent graft located in the target vessel.

5. The subject has flow-limiting stenosis or occlusion of the inflow tract that cannot be adequately corrected (= 30% residual stenosis) prior to treatment of the target lesion(s). Investigator standard of care practices shall be utilized for treatment of inflow.

6. The subject has a known contraindication (including allergic reaction) to antiplatelet/anticoagulant medications, nickel, titanium, tantalum or sensitivity.

7. The subject has a known contraindication to contrast media that is not amenable to pretreatment with steroids or/and antihistamines.

8. The subject has a known history of bleeding diatheses or coagulopathy.

9. The subject has concomitant renal failure with a creatinine of > 2.5 mg/dL.

10. The subject is currently on dialysis or receiving systemic immunosuppressive therapy.

11. The subject has known concomitant hepatic insufficiency, thrombophlebitis, uremia, systemic lupus erythematosus, septicemia or deep vein thrombosis at the time of the index procedure.

12. The subject is currently participating in an investigational drug or another investigational device study that has not completed the primary endpoint, or that clinically interferes with the study endpoints. Note: trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.

13. The subject has another medical condition, which, in the opinion of the Investigator, may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of study procedures and follow-up.

14. The subject has extensive peripheral vascular disease, which in the opinion of the Investigator, would preclude safe insertion of an introducer sheath.

15. The target lesion(s) is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion(s).

16. There is angiographic evidence of unresolved thrombus at the target lesion(s) or within the target vessel that does not resolve with infusion of thrombolytics and/or mechanical thrombectomy (using an approved device) without adverse events/complications.

17. The subject has undergone any non-iliac percutaneous intervention(s) < 7 days prior to the index procedure.

Study Design


Related Conditions & MeSH terms

  • Superficial Femoral Artery Stenosis

Intervention

Device:
PTA followed by placement of LifeStent® Vascular Stent
PTA followed by placement of LifeStent® Vascular Stent

Locations

Country Name City State
United States Kentucky Heart Foundation Ashland Kentucky
United States Steward St. Elizabeth Medical Center of Boston Inc. Boston Massachusetts
United States The Cooper Health System Camden New Jersey
United States University Surgical Associates, LLC Chattanooga Tennessee
United States Loyola University Chicago Chicago Illinois
United States BCS Heart, LLP. College Station Texas
United States South Carolina Heart Center, P.A. Columbia South Carolina
United States Saint Vincent Consultants in Cardiovascular Diseases, LLC Erie Pennsylvania
United States McLeod Regional Medical Center Florence South Carolina
United States South Florida Medical Imaging, PA Fort Lauderdale Florida
United States Houston Center for Vascular Health Houston Texas
United States The Methodist Hospital Research Institute dba Houston Methodist Research Institute Houston Texas
United States The Huntington Heart Center Huntington New York
United States Heartland Vascular Center Joliet Illinois
United States University of Kansas Medical Center Research Institute, Inc. Kansas City Kansas
United States VA Greater Los Angeles Healthcare System Los Angeles California
United States Baptist Hospital of Miami Miami Florida
United States Mount Sinai Medical Center Miami Beach Florida
United States Aurora Medical Group Milwaukee Wisconsin
United States Cardiovascular Research of Northwest Indiana, LLC. Munster Indiana
United States Saint Peter's University Hospital New Brunswick New Jersey
United States Midwest Aortic Vascular Institute P.C North Kansas City Missouri
United States Trustees of the University of Pennsylvania Philadelphia Pennsylvania
United States Allegheny-Singer Research Institute Pittsburgh Pennsylvania
United States Mission Cardiovascular Research Institute Pleasanton California
United States Sanford Research Sioux Falls South Dakota
United States Prairie Education and Research Cooperative (PERC) Springfield Illinois
United States PinnacleHealth Cardiovascular Institute Wormleysburg Pennsylvania
United States Metropolitan Hospital d/b/a Metro Health Hospital Wyoming Michigan

Sponsors (1)

Lead Sponsor Collaborator
C. R. Bard

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Primary Safety Endpoint: Freedom From Death at 30-days and 12-months Post-Index Procedure. Primary safety endpoint defined as freedom from occurrence of death at 30-days and 12-months post-index procedure. 30-days and 12-months
Primary Primary Effectiveness Endpoint: Primary Target Lesion Patency (TLP) at Time of Procedure and 12-Months Post-Index Procedure The primary effectiveness endpoint of the study, device success, collectively measured both acute and chronic effectiveness.
Acute effectiveness is defined as successful delivery of the stent to the intended site with the post-deployment stent length being within 10% of the pre-deployment stent length.
Chronic effectiveness is defined as Primary Target Lesion Patency (TLP) at 12-months post-index procedure, as measured by Duplex Ultrasound (DUS).
At time of procedure (acute) and 12-months post-index procedure (Chronic)
Secondary Freedom From Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 12-months Post-index Procedure. Target Lesion Revascularization (TLR) is defined as the interval following the index procedure until the first revascularization procedure of the target lesion. Target Vessel Revascularization (TVR) is defined as the interval following the index procedure until the first revascularization procedure (e.g. PTA, stenting, surgical bypass, etc.) in the target vessel. 12-months post-index procedure
Secondary Primary Safety: Freedom From Death at 30-days and 12-months Post-Index Procedure for Target Lesion Lengths >160 mm Compared With LifeStent 200 mm. • Primary Safety (freedom from occurrence of death at 30-days and 12-months post-index procedure) of the Target Lesion Lengths > 160 mm subgroup compared to the Target Lesions treated with the 200 mm LifeStent® subgroup. 30-days and 12-months Post -Index Procedure
Secondary Primary Effectiveness: Device Success at 12-Months Post-Index Procedure for Target Lesion Lengths > 160 mm Compared to LifeStent 200 mm. Primary Effectiveness (Device Success) of Target Lesion Lengths > 160 mm subgroup compared to the Target Lesions treated with the 200 mm LifeStent® subgroup. 12-months Post-Index Procedure
Secondary Freedom From Fracture at 12 and 24-Months Post-Index Procedure Freedom from Fracture (FFF) at 12- and 24-months post-index procedure. 12- and 24-months post-index procedure
Secondary Primary Target Lesion Patency (TLP) for Lesions > 160 mm at 12, 24, and 36 Months Post-Index Procedure Primary Target Lesion Patency (TLP) - Sustained and Expanded - for Target Lesion Lengths > 160 mm at 12-, 24- and 36-months post-index procedure corresponding to Peak Systolic Ratio (PSR) values of < 2.0, <2.5, and < 3.0. 12, 24, and 36 months Post Index Procedure
Secondary Freedom From Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 12, 24, and 36-Months Post-Index Procedure for Target Lesion Lengths > 160 mm. Freedom from Target Lesion Revascularization (TTR) and/or Target Vessel Revascularization (TRV) for Target Lesion Lengths > 160 mm at 12-, 24- and 36-months post-index procedure. 12-, 24-, and 36-months post-index procedure
Secondary Secondary Safety Endpoint: Freedom From Composite Adverse Events Secondary Safety (Freedom from Composite Adverse Events) is defined as freedom from death (excluding 30-days and 12-months post-index procedure), stroke, myocardial infarction (MI), emergent surgical revascularization, significant distal embolization in target limb, target limb major amputation, and thrombosis of target vessel at 30-days and 12-, 24-, and 36-months post-index procedure. 30-days and 12-, 24-, and 36-months post-index procedure
Secondary Number of Stents Deployed With Acute Technical Success Acute technical success is defined as successful deployment of the stent to the intended location. Intra-procedure
Secondary Number of Acute Lesion Success Acute lesion success is defined as attainment of = 30% residual stenosis of the target lesion using any percutaneous method and/or non-investigational device (i.e., post-dilatation) based on angiographic data. Intra-procedure
Secondary Number of Procedures With Acute Success Acute procedure success is defined as lesion success and no peri-procedural complications (death, stroke, MI, emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel). Intra-procedure
Secondary Sustained Freedom From Target Lesion Reintervention (TLR) and/or Target Vessel Reintervention (TVR) at 24 and 36 Months Post-Index Procedure Sustained Freedom from Target Lesion Reintervention (TLR) and/or Target Vessel Reintervention (TVR) at 24- and 36-months post-index procedure. 24- and 36-months post-index procedure
Secondary Number of Participants With Sustained Hemodynamic Success at 30-days, 12-, 24-, and 36-Months Post Index Procedure Sustained hemodynamic success is defined as sustained improvement of Ankle-Brachial Index (ABI) from baseline value of = 0.15 at 30-days and 12-, 24-, and 36-months post-index procedure without the need for repeated Target Lesion Revascularization (TLR) in surviving subjects. 30 days, 12-, 24-, and 36-months post-index procedure
Secondary Number of Participants With Sustained Clinical Success at 30-Days, 12, 24, and 36- Months Post-Index Procedure Sustained clinical success is defined as sustained cumulative improvement from baseline value of = 1 category according to Rutherford et al.12 at 30-days and 12-, 24-, and 36-months post-index procedure without the need for repeated TLR in surviving subjects. 30-days and 12-, 24-, and 36-months post-index procedure
Secondary Sustained Target Lesion Patency (TLP) at 24 and 36 Months Post-Index Procedure Sustained Target Lesion Patency (TLP) was measured at 24- and 36-months post-index procedure corresponding to PSR < 2.5. 24- and 36-months post-index procedure
Secondary Expanded Target Lesion Patency (TLP) for Peak Systolic Velocity Ratio (PSR) < 3.0 at 12, 24, and 36 Months Post-Index Procedure Expanded TLP was measured at 12-, 24- and 36-months post-index procedure corresponding to Peak Systolic Velocity Ratio (PSR) < 3.0. 12, 24, and 36 months Post-Index Procedure
Secondary Cumulative (Primary Assisted and Secondary) Target Lesion Patency (TLP) at 12, 24, and 36 Months Post-Index Procedure Cumulative (primary-assisted and secondary) Target Lesion Patency (TLP) was measured at 12-, 24-, and 36-months post-index procedure corresponding to Peak Systolic Velocity Ratio (PSR) < 2.5, and PSR < 3.0. 12, 24, and 36 Months Post-Index Procedure
Secondary Change From Baseline in Walking Impairment Questionnaire (WIQ) Results at 30-Days and 12, 24 and 36-Months Post-Index Procedure The Walking Impairment Questionnaire (WIQ) evaluation scale values range from 0 to 100, with 0 meaning inability to complete the specific task and 100 representing no difficulty in completing the task. A higher score (mean) represents an improvement in walking abilities compared to baseline measure. The results below represent, for each item measured (pain, walking distance, walking speed, and stair climbing), the mean difference between the score observed at Baseline and those observed at 30-days, 12-, 24-, and 36-months post-index procedure. 30-days, and 12-, 24-, and 36-months post-index procedure
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