Investigational Device Exemption Study to Determine the Safety and Efficacy of the Astron and Pulsar Stents (BIOFLEX-I)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biotronik, Inc.
ClinicalTrials.gov Identifier:
NCT01319812
First received: March 18, 2011
Last updated: September 26, 2014
Last verified: July 2014
  Purpose

The objective of this study is to separately demonstrate the safety and efficacy of BIOTRONIK's Astron and Pulsar stents. The Pulsar stent will be used for the treatment of femoro-popliteal lesions, located in the native superficial femoral artery (SFA) or proximal popliteal artery (PPA), while the Astron stent will be used for the treatment of the common or external iliac artery lesions.


Condition Intervention Phase
Peripheral Artery Disease
Peripheral Vascular Disease
Device: Astron/Pulsar Stents
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Treatment of Iliac and Femoral Atherosclerotic Lesions Using the Self-expanding Astron and Pulsar Stents

Resource links provided by NLM:


Further study details as provided by Biotronik, Inc.:

Primary Outcome Measures:
  • Effectiveness Endpoint for the Pulsar Stent [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The primary effectiveness endpoint for the Pulsar stent group is the primary patency rate at 12 months post-index procedure. Primary patency is defined as freedom from more than 50% restenosis based on the duplex ultrasound peak systolic velocity ratio, comparing data within the treated segment to the proximal normal segment or based on a clinically-indicated TLR with angiographic evidence of > 50% stenosis.

  • Safety Endpoint for the Pulsar Stent [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    The primary safety endpoint for the Pulsar stent is the freedom from procedure- or stent-related major adverse events at 30 days post-index procedure. The major adverse event rate includes mortality, target lesion revascularization and index limb amputation.

  • Safety and Effectiveness Endpoint for the Astron Stent [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    The primary endpoint for the Astron stent is a composite of the rate of procedure- or stent-related major adverse events at 12 months post-index procedure. The major adverse event rate includes 30-day mortality, along with 12-month rates of target lesion revascularization and index limb amputation.


Secondary Outcome Measures:
  • Secondary Safety Assessment for the Pulsar Stent [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Evaluate the contribution of the individual rates of mortality, target lesion revascularization and index limb amputation at 30 days post-index procedure to the primary safety endpoint for the Pulsar stent.

  • Long-Term Safety Assessment for the Pulsar Stent [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Evaluate the long-term major adverse event rate of the Pulsar stent. Likewise, the endpoint will evaluate the contribution of the individual rates of 30-day mortality and 12-month target lesion revascularization and index limb amputation rates to this overall, long-term major adverse event rate.

  • Stent Integrity Assessment for the Pulsar Stent [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Evaluate the Pulsar stent integrity as measured by x-ray at 12 months post-index procedure.

  • Secondary Safety Assessment for the Astron Stent [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Evaluate the contribution of the individual rates of 30-day mortality and 12-month target lesion revascularization and index limb amputation rates to the primary endpoint for the Astron stent.

  • Secondary Effectiveness Assessment for the Astron Stent [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Evaluate the primary patency of the Astron stent at 12 months post-index procedure as measured by duplex ultrasound.

  • Functional Assessments for Subjects with the Astron and Pulsar Stents [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The purpose of this endpoint is to compare the ABI measurements, distance walked during the 6-minute walk test and scores on the Walking Impairment Questionnaire between baseline and 12 months post-index procedure.

  • Secondary Effectiveness Assessment for the Astron and Pulsar Stents [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Evaluate the primary assisted patency rate and the secondary patency rate for the Astron and Pulsar stent at 12 months post-index procedure

  • Acute Procedural success for Astron and Pulsar stent [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Evaluate the acute procedural success of the Astron and Pulsar stent.

  • Clinical Success [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Evaluate the 30-day clinical success of the procedure.

  • Secondary Safety Assessment for Astron and Pulsar Stent [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
    Evaluate the rates of all individual adverse event types that are not included in the primary endpoint analyses for the Astron stent and the Pulsar stent group.

  • Comparison of Endpoints Results Between Short and Long Lesions for Pulsar Stent [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Compare the primary and secondary endpoint results between evaluable subjects in the Pulsar stent group with lesions from 20 mm to 140 mm in length and evaluable subjects with lesions from 141 mm to 190 mm in length.

  • Comparison fof Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Compare the primary and secondary endpoint results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group.


Estimated Enrollment: 456
Study Start Date: July 2011
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Investigational Stent Device: Astron/Pulsar Stents
Implantation of self-expanding, bare-metal, nitinol stents for treatment of peripheral artery disease.
Other Names:
  • Astron Stent
  • Astron Pulsar Stent
  • Pulsar-18 Stent
  • Pulsar Stent

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

To support the objectives of this study, the following initial inclusion criteria must be met for a subject to be enrolled and considered for the index procedure:

  • Age ≥ 18 years
  • Willingness to comply with study follow-up requirements
  • Candidate for PTA
  • Life-style limiting claudication or rest pain with an ABI ≤ 0.9 (resting or exercise). Thigh brachial index (TBI) may be used / performed if ABI is inadequate.
  • Written informed consent

For a subject to receive an investigational stent, the following procedure-related criteria must be met:

  • One de novo, restenotic or occluded lesion representing a femoro-popliteal or iliac indication OR Two de novo, restenotic or occluded lesions representing one femoro-popliteal indication and one iliac indication on contralateral limbs - (i.e. one lesion per limb)
  • Lesions may be one solid lesion or a series of multiple, smaller lesions to be treated as one lesion
  • Subjects with bilateral, SFA/PPA disease (i.e. one SFA/PPA lesion per limb) are eligible for enrollment into the study. The target lesion will be selected at the investigator's discretion based on study eligibility criteria. The contralateral SFA/PPA intervention may be performed at the time of the index procedure (prior to treatment of study lesion); however, the use of an investigational treatment is prohibited. If the contralateral SFA/PPA intervention is not performed at the time of the index procedure, the intervention must be performed at least 30 days after the index procedure. The use of an investigational treatment for the contralateral intervention is prohibited.
  • Subjects with bilateral, iliac disease (i.e. one iliac lesion per limb) are eligible for enrollment into the study. The target lesion will be selected at the investigator's discretion based on study eligibility criteria. The contralateral iliac intervention may be performed at the time of the index procedure; however, the use of an investigational treatment is prohibited. If the contralateral iliac intervention is not performed at the time of the index procedure, the intervention must be performed at least 30 days after the index procedure. The use of an investigational treatment for the subsequent contralateral intervention is also prohibited.
  • Femoro-popliteal lesions must be located at least 1 cm distal to the profunda femoris artery and at least 3 cm above the knee joint (radiographic joint space)
  • Iliac lesions must be located only in either the common or external iliac artery
  • Lesions must be treatable with a maximum of two stents
  • Angiographic evidence of ≥ 70% stenosis or occlusion (operator visual assessment)
  • Lesion length ≤ 190 mm (if de novo or restenotic) or ≤ 100 mm (if occluded)
  • Target vessel reference diameter: 2.5 to 6 mm (SFA/PPA) or 6 to 9 mm (iliac arteries) by visual estimate
  • Angiographic evidence of patent SFA and PPA (iliac indication) and angiographic evidence of at least one distal vessel runoff to the foot (both femoro-popliteal and iliac indications). Patent is defined as < 50% stenosis.
  • For SFA/PPA intervention, a significant stenosis (> 70%) or occlusion of an ipsilateral, inflow artery (e.g. aortoiliac, common femoral) must be successfully treated (use of investigational treatment prohibited) just prior to treatment of the target lesion. Successful treatment is defined as no complications and less than 30% residual stenosis following intervention.

Exclusion Criteria

To support the objectives of this study, the following initial exclusion criteria must not be present for a subject to be enrolled:

  • Subjects pregnant or planning to become pregnant during the course of the study
  • Life expectancy of less than one year
  • Rutherford-Becker category 5 or 6. Subjects with ulcers caused by venous disease may be enrolled in the study.
  • Previously stented lesion(s) in the target vessel
  • Target lesion(s) received previous treatment within 30 days prior to enrollment
  • Prior peripheral vascular bypass surgery involving the target limb(s)
  • Thrombophlebitis or deep vein thrombosis within the past 30 days
  • Known allergy to nitinol (nickel and/or titanium)
  • Participation in any other clinical investigational device or drug study. Subjects may be concurrently enrolled in a post-market study, as long as the post-market study device, drug or protocol does not interfere with the investigational treatment or protocol of this study.
  • Previous stroke or transient ischemic attack within the last three months prior to enrollment
  • Previous coronary or peripheral bypass surgery (non-target limb) within 30 days prior to enrollment
  • Intolerance to contrast agents that cannot be medically managed and/or intolerance to anti-platelet, anti-coagulant or thrombolytic medications
  • Refuses blood transfusions
  • Any medical condition, that in the opinion of the investigator, poses an unacceptable risk for implant of a stent according to the study indications

For a subject to receive an investigational stent the following procedure-related criteria must not be present:

  • INR ≥ 1.6
  • Concomitant renal failure with serum creatinine level > 2.5 mg/dL
  • Unresolved neutropenia (white blood cell count < 3,000 / µL) or thrombocytopenia (platelet count < 80,000 / µL) at the time of the index procedure
  • Unresolved bleeding disorder (INR ≥ 1.6) at the time of the index procedure
  • Presence of other ipsilateral, arterial lesions distal to the target lesion requiring treatment within 30 days of the index procedure (either before or after) or at the time of the index procedure
  • Additional percutaneous interventional procedures (cardiac and/or peripheral) planned within 30 days after the index procedure
  • Presence of a complication following pre-dilation of target lesion
  • Presence of a target vessel/lesion that is excessively tortuous or calcified or is adjacent to an acute thrombus that is unresponsive to anti-thrombotic therapies
  • Target lesion is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion
  • Target lesion requires the use of cutting balloons, atherectomy or ablative devices
  • Subjects with less than single vessel runoff to the foot
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01319812

  Hide Study Locations
Locations
United States, California
Fremont, California, United States, 94538
United States, Connecticut
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Washington, District of Columbia, United States, 20010
United States, Illinois
Rockford, Illinois, United States, 61107
United States, Indiana
Munster, Indiana, United States, 46321
United States, Louisiana
Houma, Louisiana, United States, 70360
United States, Michigan
Lansing, Michigan, United States, 48912
Saginaw, Michigan, United States, 48601
Wyoming, Michigan, United States, 49519
Ypsilanti, Michigan, United States, 48197
United States, Mississippi
Tupelo, Mississippi, United States, 38801
United States, Missouri
Kansas City, Missouri, United States, 64114
United States, New Jersey
Ridgewood, New Jersey, United States, 07450
United States, New York
Bronx, New York, United States, 10467
New York, New York, United States, 10065
United States, North Carolina
Gastonia, North Carolina, United States, 28054
High Point, North Carolina, United States, 27262
United States, Ohio
Cincinnati, Ohio, United States, 45267
Toledo, Ohio, United States, 43614
Toledo, Ohio, United States, 43606
United States, Pennsylvania
Camp Hill, Pennsylvania, United States, 17011
Doylestown, Pennsylvania, United States, 18901
Langhorne, Pennsylvania, United States, 19047
Pittsburgh, Pennsylvania, United States, 15232
United States, Rhode Island
Providence, Rhode Island, United States, 02906
United States, South Carolina
Greenville, South Carolina, United States, 29605
Rock Hill, South Carolina, United States, 29732
United States, Tennessee
Kingsport, Tennessee, United States, 37660
United States, Texas
Amarillo, Texas, United States, 79106
Austin, Texas, United States, 78745
McKinney, Texas, United States, 75069
Tyler, Texas, United States, 75701
Waco, Texas, United States, 76712
Canada
Montreal, Canada
Toronto, Canada
Sponsors and Collaborators
Biotronik, Inc.
Investigators
Principal Investigator: Mark Burket, MD University of Toledo
  More Information

No publications provided

Responsible Party: Biotronik, Inc.
ClinicalTrials.gov Identifier: NCT01319812     History of Changes
Other Study ID Numbers: BIOFLEX-I
Study First Received: March 18, 2011
Last Updated: September 26, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Biotronik, Inc.:
Vascular intervention
Endovascular
Peripheral stent

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014