BARD® Study of LIFESTREAM™ Balloon Expandable Covered Stent Treating Iliac Arterial Occlusive Disease

NCT02228564 | Completed Results FDA Device

• 1 other identifier: BPV-12-001
• Study Type: interventional
• Target: 155
• Locations: 3 countries
• Sites: 20

Brief Summary

Collect confirmatory evidence of the safety and effectiveness of the Balloon LIFESTREAM™ Stent Graft for the treatment of stenoses and occlusion in the iliac arteries.

Conditions

Peripheral Artery Disease; Peripheral Vascular Disease; Arterial Occlusive Disease

Keywords

Lack of perfusion in the extremities; Atherosclerosis; Intermittent claudication; BOLSTER

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Device and/or Procedure-Related Death or Myocardial Infarction (MI) Through 30 Days, or Any Target Lesion Revascularization (TLR), Target Limb(s) Major Amputation, or Restenosis Through 9-Months Post Index Procedure.

  The primary endpoint is a composite safety and effectiveness measure defined as device and/or procedure-related death or myocardial infarction (MI) through 30 days, or any Target Lesion Revascularization (TLR), target limb(s) major amputation, or restenosis through 9-months post-index procedure.

  9 months post index procedure

Secondary Outcomes (11)

• Number of Participants With Major Adverse Events (MAEs) Through 9-Months Post Index Procedure.

  9 months post index procedure

• Number of Lesions With Acute Lesion Success

  At time of Index Procedure

• Number of Participants With Acute Procedure Success

  At time of hospital discharge

• Number of Devices With Acute Technical Success at Index Procedure

  At time of index procedure

• Number of Participants With Target Lesion Revascularization (TLR) at 6, 9, 12, 24, and 36 Months Post Index Procedure

  6, 9, 12, 24, and 36 months post index procedure

Study Arms (1)

LIFESTREAM™

EXPERIMENTAL

This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.

Procedure: Percutaneous transluminal angioplasty (PTA); Device: LIFESTREAM™ covered stent

Interventions

Percutaneous transluminal angioplasty (PTA) PROCEDURE

Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

LIFESTREAM™

LIFESTREAM™ covered stent DEVICE

Implantation of the LIFESTREAM™ covered stent

LIFESTREAM™

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 approved by the Ethics Committee/ Institutional Review Board for the site.
• Subject agrees to comply with the protocol-mandated follow-up procedures and visits.
• Subject is a male or non-pregnant female ≥ 21 years old with an expected lifespan sufficient to allow for completion of all study procedures.
• Subject has intermittent claudication (Rutherford Category 2-3) or ischemic rest pain (Rutherford Category 4).
• Subject is able and willing to comply with any required medication regimen.
• Subject has evidence of single, bilateral, or multiple de novo and/or restenotic (non-stented) lesion in the native common and/or external iliac artery that is ≥ 50% stenosed (including total occlusions).
• The target lesion can be successfully crossed with a guide wire and pre-dilated with an appropriately sized PTA balloon.
• The reference vessel diameter is between 4.5 mm -12.0 mm in diameter.
• The target lesion is ≤ 100 mm in combined length (per side).
• The subject has angiographic evidence of a patent (\< 50% stenosis) profunda and/or superficial femoral artery (SFA) in the target limb.

You may not qualify if:

• The subject is unable or unwilling to provide written informed consent or to conform to the study protocol follow-up procedures and visits.
• The subject is or plans to become pregnant during the study.
• The subject is asymptomatic, has mild claudication or critical limb ischemia with tissue loss described as Rutherford Category 0, 1, 5 or 6.
• The subject has a vascular graft previously implanted in the native iliac vessel.
• The subject suffered a hemorrhagic stroke or transient ischemic attack (TIA) within 3 months prior to the index procedure.
• The subject has a known uncorrectable bleeding diathesis or active coagulopathy.
• The subject has a serum creatinine ≥ 2.5 mg/dl or is on dialysis.
• The subject has a known allergy or sensitivity to stainless steel (i.e., Nickel), ePTFE, or has intolerance to the antiplatelet, anticoagulant or thrombolytic medications required per the protocol.
• The subject has a known allergy or sensitivity to contrast media, which cannot be adequately pre-medicated.
• The subject had a prior vascular intervention within 30 days before or planned for within 30 days after the index procedure.
• The subject has another medical condition, which 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 is currently participating in an investigational drug, biologic, or another device study.
• The subject has extensive peripheral vascular disease, which in the opinion of the Investigator, would preclude safe insertion of an introducer sheath. The ipsilateral common femoral artery should be patent (\< 50% stenosis).
• The target lesion requires treatment other than angioplasty to facilitate subject device delivery.
• The subject has severe calcification of the target lesion, preventing inflation of PTA balloon.

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (20)

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

Vascular and Interventional Specialists of Orange County

Orange, California, 91107, United States

Location

UC Davis Cardiovascular Medicine

Sacramento, California, 95817, United States

Location

Florida Research Network

Gainesville, Florida, 32605, United States

Location

Baptist Medical Center

Jacksonville, Florida, 32207, United States

Location

Lakeland Regional Medical Center

Lakeland, Florida, 33805, United States

Location

Mount Sinai Medical Center

Miami, Florida, 33140, United States

Location

University of Massachusetts Worcester

Worcester, Massachusetts, 01655, United States

Location

Kansas City Vascular Foundation

Kansas City, Missouri, 64116, United States

Location

CaroMont Regional Medical Center

Gastonia, North Carolina, 28054, United States

Location

North Carolina Heart and Vascular

Raleigh, North Carolina, 27607, United States

Location

Donald Guthrie Foundation

Sayre, Pennsylvania, 18840, United States

Location

Univeristy of Texas Medical Branch

Galveston, Texas, 77550, United States

Location

Swedish Health Services

Seattle, Washington, 98122, United States

Location

Universitäts-Herzzentrum Freiburg-Bad Krozingen GmbH

Bad Krozingen, 79189, Germany

Location

Ev.Krankenhaus Königin Elisabeth

Berlin, 10365, Germany

Location

Praxis fur Interventionelle Angiologie

Kaiserslautern, 67657, Germany

Location

Universitaetsklinikum Leipzig

Leipzig, 04289, Germany

Location

Bonifatius Hospital

Lingen, 49808, Germany

Location

Auckland Hospital

Auckland, New Zealand

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Peripheral Vascular Diseases; Arterial Occlusive Diseases; Atherosclerosis; Intermittent Claudication

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Arteriosclerosis; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Results Point of Contact

• Title: Spark Yamanoglu
• Organization: Becton Dickinson

Spark.yamanoglu@bd.com

480-597-8604

Study Officials

• John R Laird, M.D.

  U. C. Davis Medical Center

  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: August 15, 2014
• First Posted: August 29, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2018
• Last Updated: October 8, 2020
• Results First Posted: October 8, 2020

Record last verified: 2020-09

Locations

DE (5); US (14); NZ (1)