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

NCT00908947 | Terminated Results DMC FDA Device

• 1 other identifier: BPV-08-001
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 29

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").

Conditions

Superficial Femoral Artery Stenosis

Keywords

SFA; Stent; Popliteal; infrainguinal; LifeStent; Peripheral; Arterial

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (17)

• Freedom From Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 12-months Post-index Procedure.

  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.

  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.

  12-months Post-Index Procedure

• Freedom From Fracture 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

  12, 24, and 36 months Post Index Procedure

Study Arms (1)

Overall Study

EXPERIMENTAL

PTA plus stenting with the LifeStent® Vascular Stent System

Device: PTA followed by placement of LifeStent® Vascular Stent

Interventions

PTA followed by placement of LifeStent® Vascular Stent DEVICE

PTA followed by placement of LifeStent® Vascular Stent

Also known as: LifeStent® Vascular Stent; LifeStent® XL Vascular Stent; LifeStent® SOLO(TM) Vascular Stent

Overall Study

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Subject agrees to comply with the protocol-mandated follow-up procedures and visits.
• The subject is ≥ 21 years old.
• Male or female subjects; female subjects of childbearing potential must have a negative urine pregnancy test at the time of screening.
• The subject has lifestyle-limiting claudication or ischemic rest pain defined as: Rutherford Category 2-4.
• The target lesion(s) has angiographic evidence of stenosis or restenosis ≥ 50% or occlusion (by visual estimate) and is amenable to PTA with stenting.
• The total target lesion(s) length must be ≤ 240 mm.
• 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.

You may not qualify if:

• 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.
• The subject has claudication or critical limb ischemia described as Rutherford Category 1 (mild claudication), 5 (minor tissue loss) or 6 (major tissue loss.
• The subject has multiple stenoses or occlusions \> 240 mm.
• The subject has a previous stent or stent graft located in the target vessel.
• 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.
• The subject has a known contraindication (including allergic reaction) to antiplatelet/anticoagulant medications, nickel, titanium, tantalum or sensitivity.
• The subject has a known contraindication to contrast media that is not amenable to pretreatment with steroids or/and antihistamines.
• The subject has a known history of bleeding diatheses or coagulopathy.
• The subject has concomitant renal failure with a creatinine of \> 2.5 mg/dL.
• The subject is currently on dialysis or receiving systemic immunosuppressive therapy.
• The subject has known concomitant hepatic insufficiency, thrombophlebitis, uremia, systemic lupus erythematosus, septicemia or deep vein thrombosis at the time of the index procedure.
• 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.
• 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.
• The subject has extensive peripheral vascular disease, which in the opinion of the Investigator, would preclude safe insertion of an introducer sheath.
• 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).

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (29)

VA Greater Los Angeles Healthcare System

Los Angeles, California, 90073, United States

Location

Mission Cardiovascular Research Institute

Pleasanton, California, 94588, United States

Location

South Florida Medical Imaging, PA

Fort Lauderdale, Florida, 33308, United States

Location

Baptist Hospital of Miami

Miami, Florida, 33176, United States

Location

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Loyola University Chicago

Chicago, Illinois, 60637, United States

Location

Heartland Vascular Center

Joliet, Illinois, 60435, United States

Location

Prairie Education and Research Cooperative (PERC)

Springfield, Illinois, 62701, United States

Location

Cardiovascular Research of Northwest Indiana, LLC.

Munster, Indiana, 46321, United States

Location

University of Kansas Medical Center Research Institute, Inc.

Kansas City, Kansas, 66160, United States

Location

Kentucky Heart Foundation

Ashland, Kentucky, 41101, United States

Location

Steward St. Elizabeth Medical Center of Boston Inc.

Boston, Massachusetts, 02135, United States

Location

Metropolitan Hospital d/b/a Metro Health Hospital

Wyoming, Michigan, 49509, United States

Location

Midwest Aortic Vascular Institute P.C

North Kansas City, Missouri, 64116, United States

Location

The Cooper Health System

Camden, New Jersey, 08103, United States

Location

Saint Peter's University Hospital

New Brunswick, New Jersey, 08901, United States

Location

The Huntington Heart Center

Huntington, New York, 11743, United States

Location

Saint Vincent Consultants in Cardiovascular Diseases, LLC

Erie, Pennsylvania, 16502, United States

Location

Trustees of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Allegheny-Singer Research Institute

Pittsburgh, Pennsylvania, 15212, United States

Location

PinnacleHealth Cardiovascular Institute

Wormleysburg, Pennsylvania, 17043, United States

Location

South Carolina Heart Center, P.A.

Columbia, South Carolina, 29204, United States

Location

McLeod Regional Medical Center

Florence, South Carolina, 29501, United States

Location

Sanford Research

Sioux Falls, South Dakota, 57104, United States

Location

University Surgical Associates, LLC

Chattanooga, Tennessee, 37403, United States

Location

BCS Heart, LLP.

College Station, Texas, 77845, United States

Location

Houston Center for Vascular Health

Houston, Texas, 77030, United States

Location

The Methodist Hospital Research Institute dba Houston Methodist Research Institute

Houston, Texas, 77030, United States

Location

Aurora Medical Group

Milwaukee, Wisconsin, 53215, United States

Location

Results Point of Contact

• Title: Talar Saber, Senior Project Manager, Clinical Affairs
• Organization: BD/Bard

Talar.Saber@crbard.com

1.480.379.2839

Study Officials

• Jeffrey P Carpenter, MD

  The Cooper Health System

  PRINCIPAL INVESTIGATOR

• Mark D Mewissen, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2009
• First Posted: May 27, 2009
• Study Start: February 1, 2011
• Primary Completion: September 18, 2018
• Study Completion: September 19, 2018
• Last Updated: November 19, 2019
• Results First Posted: November 6, 2019

Record last verified: 2019-11

Locations

US (29)