Clinical trial NCT00908947: CONTINuous Infra-Inguinal Stenting Using the Bard® LifeStent® VascUlar Stent SysteMs ("CONTINUUM")
Official title: CONTINuous Infra-Inguinal Stenting Using the Bard® LifeStent® VascUlar Stent SysteMs ("CONTINUUM")
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Superficial Femoral Artery Stenosis
Keywords: SFA
Stent
Popliteal
infrainguinal
LifeStent
Peripheral
Arterial
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2009-05-27
Enrollment: 173
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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").

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary Safety Endpoint: Freedom From Death at 30-days and 12-months Post-Index Procedure.
timeFrame: 30-days and 12-months
measure: Primary Effectiveness Endpoint: Primary Target Lesion Patency (TLP) at Time of Procedure and 12-Months Post-Index Procedure
timeFrame: At time of procedure (acute) and 12-months post-index procedure (Chronic)
Secondary outcomes:
measure: Freedom From Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 12-months Post-index Procedure.
timeFrame: 12-months post-index procedure
measure: 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.
timeFrame: 30-days and 12-months Post -Index Procedure
measure: Primary Effectiveness: Device Success at 12-Months Post-Index Procedure for Target Lesion Lengths > 160 mm Compared to LifeStent 200 mm.
timeFrame: 12-months Post-Index Procedure
measure: Freedom From Fracture at 12 and 24-Months Post-Index Procedure
timeFrame: 12- and 24-months post-index procedure
measure: Primary Target Lesion Patency (TLP) for Lesions > 160 mm at 12, 24, and 36 Months Post-Index Procedure
timeFrame: 12, 24, and 36 months Post Index Procedure
measure: 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.
timeFrame: 12-, 24-, and 36-months post-index procedure
measure: Secondary Safety Endpoint: Freedom From Composite Adverse Events
timeFrame: 30-days and 12-, 24-, and 36-months post-index procedure
measure: Number of Stents Deployed With Acute Technical Success
timeFrame: Intra-procedure
measure: Number of Acute Lesion Success
timeFrame: Intra-procedure
measure: Number of Procedures With Acute Success
timeFrame: Intra-procedure
measure: Sustained Freedom From Target Lesion Reintervention (TLR) and/or Target Vessel Reintervention (TVR) at 24 and 36 Months Post-Index Procedure
timeFrame: 24- and 36-months post-index procedure
measure: Number of Participants With Sustained Hemodynamic Success at 30-days, 12-, 24-, and 36-Months Post Index Procedure
timeFrame: 30 days, 12-, 24-, and 36-months post-index procedure
measure: Number of Participants With Sustained Clinical Success at 30-Days, 12, 24, and 36- Months Post-Index Procedure
timeFrame: 30-days and 12-, 24-, and 36-months post-index procedure
measure: Sustained Target Lesion Patency (TLP) at 24 and 36 Months Post-Index Procedure
timeFrame: 24- and 36-months post-index procedure
measure: Expanded Target Lesion Patency (TLP) for Peak Systolic Velocity Ratio (PSR) < 3.0 at 12, 24, and 36 Months Post-Index Procedure
timeFrame: 12, 24, and 36 months Post-Index Procedure
measure: Cumulative (Primary Assisted and Secondary) Target Lesion Patency (TLP) at 12, 24, and 36 Months Post-Index Procedure
timeFrame: 12, 24, and 36 Months Post-Index Procedure
measure: Change From Baseline in Walking Impairment Questionnaire (WIQ) Results at 30-Days and 12, 24 and 36-Months Post-Index Procedure
timeFrame: 30-days, and 12-, 24-, and 36-months post-index procedure
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System
state: California
city: Pleasanton
country: United States
facility: Mission Cardiovascular Research Institute
state: California
city: Fort Lauderdale
country: United States
facility: South Florida Medical Imaging, PA
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Miami
country: United States
facility: Baptist Hospital of Miami
state: Florida
city: Chicago
country: United States
facility: Loyola University Chicago
state: Illinois
city: Joliet
country: United States
facility: Heartland Vascular Center
state: Illinois
city: Springfield
country: United States
facility: Prairie Education and Research Cooperative (PERC)
state: Illinois
city: Munster
country: United States
facility: Cardiovascular Research of Northwest Indiana, LLC.
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center Research Institute, Inc.
state: Kansas
city: Ashland
country: United States
facility: Kentucky Heart Foundation
state: Kentucky
city: Boston
country: United States
facility: Steward St. Elizabeth Medical Center of Boston Inc.
state: Massachusetts
city: Wyoming
country: United States
facility: Metropolitan Hospital d/b/a Metro Health Hospital
state: Michigan
city: North Kansas City
country: United States
facility: Midwest Aortic Vascular Institute P.C
state: Missouri
city: Camden
country: United States
facility: The Cooper Health System
state: New Jersey
city: New Brunswick
country: United States
facility: Saint Peter's University Hospital
state: New Jersey
city: Huntington
country: United States
facility: The Huntington Heart Center
state: New York
city: Erie
country: United States
facility: Saint Vincent Consultants in Cardiovascular Diseases, LLC
state: Pennsylvania
city: Philadelphia
country: United States
facility: Trustees of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny-Singer Research Institute
state: Pennsylvania
city: Wormleysburg
country: United States
facility: PinnacleHealth Cardiovascular Institute
state: Pennsylvania
city: Columbia
country: United States
facility: South Carolina Heart Center, P.A.
state: South Carolina
city: Florence
country: United States
facility: McLeod Regional Medical Center
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford Research
state: South Dakota
city: Chattanooga
country: United States
facility: University Surgical Associates, LLC
state: Tennessee
city: College Station
country: United States
facility: BCS Heart, LLP.
state: Texas
city: Houston
country: United States
facility: Houston Center for Vascular Health
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital Research Institute dba Houston Methodist Research Institute
state: Texas
city: Milwaukee
country: United States
facility: Aurora Medical Group
state: Wisconsin
Study officials:
affiliation: The Cooper Health System
name: Jeffrey P Carpenter, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Forest University Health Sciences
name: Mark D Mewissen, MD
role: PRINCIPAL_INVESTIGATOR
References: