CONTINuous Infra-Inguinal Stenting Using the Bard® LifeStent® VascUlar Stent SysteMs ("CONTINUUM") (CONTINUUM)

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").

Study Overview

• Status: Terminated
• Conditions: Superficial Femoral Artery Stenosis
• Intervention / Treatment: Device: PTA followed by placement of LifeStent® Vascular Stent

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.

• Study Type: Interventional
• Enrollment (Actual): 173
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90073
      • VA Greater Los Angeles Healthcare System
    • Pleasanton, California, United States, 94588
      • Mission Cardiovascular Research Institute
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • South Florida Medical Imaging, PA
    • Miami, Florida, United States, 33176
      • Baptist Hospital of Miami
    • Miami Beach, Florida, United States, 33140
      • Mount Sinai Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Loyola University Chicago
    • Joliet, Illinois, United States, 60435
      • Heartland Vascular Center
    • Springfield, Illinois, United States, 62701
      • Prairie Education and Research Cooperative (PERC)
  • Indiana
    • Munster, Indiana, United States, 46321
      • Cardiovascular Research of Northwest Indiana, LLC.
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center Research Institute, Inc.
  • Kentucky
    • Ashland, Kentucky, United States, 41101
      • Kentucky Heart Foundation
  • Massachusetts
    • Boston, Massachusetts, United States, 02135
      • Steward St. Elizabeth Medical Center of Boston Inc.
  • Michigan
    • Wyoming, Michigan, United States, 49509
      • Metropolitan Hospital d/b/a Metro Health Hospital
  • Missouri
    • North Kansas City, Missouri, United States, 64116
      • Midwest Aortic Vascular Institute P.C
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • The Cooper Health System
    • New Brunswick, New Jersey, United States, 08901
      • Saint Peter's University Hospital
  • New York
    • Huntington, New York, United States, 11743
      • The Huntington Heart Center
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16502
      • Saint Vincent Consultants in Cardiovascular Diseases, LLC
    • Philadelphia, Pennsylvania, United States, 19104
      • Trustees of the University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny-Singer Research Institute
    • Wormleysburg, Pennsylvania, United States, 17043
      • PinnacleHealth Cardiovascular Institute
  • South Carolina
    • Columbia, South Carolina, United States, 29204
      • South Carolina Heart Center, P.A.
    • Florence, South Carolina, United States, 29501
      • McLeod Regional Medical Center
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57104
      • Sanford Research
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • University Surgical Associates, LLC
  • Texas
    • College Station, Texas, United States, 77845
      • BCS Heart, LLP.
    • Houston, Texas, United States, 77030
      • The Methodist Hospital Research Institute dba Houston Methodist Research Institute
    • Houston, Texas, United States, 77030
      • Houston Center for Vascular Health
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora Medical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Overall Study; PTA plus stenting with the LifeStent® Vascular Stent System	Device: PTA followed by placement of LifeStent® Vascular Stent; PTA followed by placement of LifeStent® Vascular Stent; Other Names: LifeStent® Vascular Stent; LifeStent® XL Vascular Stent; LifeStent® SOLO(TM) Vascular Stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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 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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: C. R. Bard
• Investigators: Principal Investigator: Jeffrey P Carpenter, MD, The Cooper Health System; Principal Investigator: Mark D Mewissen, MD, Aurora Health Care

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): September 18, 2018
• Study Completion (Actual): September 19, 2018

Study Registration Dates

• First Submitted: May 26, 2009
• First Submitted That Met QC Criteria: May 26, 2009
• First Posted (Estimate): May 27, 2009

Study Record Updates

• Last Update Posted (Actual): November 19, 2019
• Last Update Submitted That Met QC Criteria: November 5, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Stent; Peripheral; SFA; Arterial; LifeStent; Popliteal; infrainguinal
• Other Study ID Numbers: BPV-08-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes