Clinical trial NCT01319812: Investigational Device Exemption Study to Determine the Safety and Efficacy of the Astron and Pulsar Stents
Official title: The Treatment of Iliac and Femoral Atherosclerotic Lesions Using the Self-expanding Astron and Pulsar Stents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peripheral Artery Disease
Peripheral Vascular Disease
Keywords: Vascular intervention
Endovascular
Peripheral stent
Lead sponsor: Biotronik, Inc.
Sponsor class: INDUSTRY
First posted: 2011-03-22
Enrollment: 463
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Effectiveness Endpoint for the Pulsar Stent: Primary Patency
timeFrame: 12 months
measure: Safety Endpoint for the Pulsar Stent: Freedom From Procedure- or Stent-related Major Adverse Events
timeFrame: 30 days
measure: Safety and Effectiveness Endpoint for the Astron Stent - Percentage of Participants With Major Adverse Events (MAE)
timeFrame: 12 months
measure: Percentage of Participants With Primary Safety Endpoint (Post Market Analysis)
timeFrame: 36 Months
Secondary outcomes:
measure: Secondary Safety Assessment for the Pulsar Stent: Individual Rates of Mortality, TLR, and Index Limb Amputation
timeFrame: 30 days
measure: Long-Term Safety Assessment for the Pulsar Stent: Major Adverse Event Rate
timeFrame: 12 months
measure: Stent Integrity Assessment for the Pulsar Stent: Stent Fracture Rate
timeFrame: 12 months
measure: Secondary Safety Assessment for the Astron Stent - Distribution of MAE Rate
timeFrame: 12 months
measure: Secondary Effectiveness Assessment for the Astron Stent - Primary Patency Rate
timeFrame: 12 months
measure: Secondary Effectiveness Assessment for the Astron and Pulsar Stents - Primary Assisted Patency
timeFrame: 12 months
measure: Secondary Effectiveness Assessment for the Astron and Pulsar Stents - Secondary Patency
timeFrame: 12 months
measure: Functional Assessments for Subjects With the Astron and Pulsar Stents - Ankle - Brachial Index (ABI) Measurement
timeFrame: 12 months
measure: Functional Assessments for Subjects With the Astron and Pulsar Stents - Six-Minute Walk Test
timeFrame: 12 months
measure: Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire PAD Specific Score
timeFrame: 12 months
measure: Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Walking Distance Score
timeFrame: 12 months
measure: Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Walking Speed Score
timeFrame: 12 months
measure: Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Stair Climbing Score
timeFrame: 12 months
measure: Acute Procedural Success for Astron and Pulsar Stent
timeFrame: 30 days
measure: Clinical Success
timeFrame: 30 days
measure: Secondary Safety Assessment for Astron and Pulsar Stent: Adverse Event Rates
timeFrame: 12 month
measure: Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - 30 Day MAE Rate
timeFrame: 30 days
measure: Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Primary Patency at 12-months
timeFrame: 12 months
measure: Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Primary Assisted Patency at 12-Months
timeFrame: 12 months
measure: Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Secondary Patency Rate at 12-Months
timeFrame: 12 months
measure: Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Acute Procedure Success
timeFrame: Acute / Date of Procedure
measure: Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - 30-Day Clinical Success
timeFrame: 30 days
measure: Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - MAE Rate
timeFrame: 12 months
measure: Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Primary Patency at 12 Months
timeFrame: 12 months
measure: Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Stent Fracture Rate at 12 Months
timeFrame: 12 months
measure: Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Primary Assisted Patency at 12 Months
timeFrame: 12 months
measure: Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Secondary Patency Rate at 12 Months
timeFrame: 12 months
measure: Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Acute Procedure Success
timeFrame: Acute / Date of Procedure
measure: Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - 30-day Clinical Success
timeFrame: 30 days
measure: Number of Participants With Freedom From Clinically-driven TLR and Index Limb Amputation at 24 Months (Post Approval)
timeFrame: 24 Months
measure: Safety Assessment for the Pulsar Stent: Percentage of Participants With Mortality, TLR, and Index Limb Amputation (Post Approval)
timeFrame: 24 Months
measure: Percentage of Participants for the Pulsar Stent Group With MAE (30-day Mortality, Clinically-driven TLR, and Index Limb Amputation) and Their Components at 36 Months (Post Approval).
timeFrame: 36 Months
measure: Percentage of Participants With Target Lesion Revascularization (TLR) at 24 Months (Post Approval) (Pulsar Stent Group)
timeFrame: 24 Months
measure: Percentage of Participants With Target Lesion Revascularization (TLR) at 36 Months (Post Approval) (Pulsar Stent Group)
timeFrame: 36 Months
measure: Number of Participants With Stent Fracture at 24 Months (Post Approval).
timeFrame: 24 Months
measure: Number of Participants With Stent Fracture at 36 Months (Post Approval) (Pulsar Stent Group).
timeFrame: 36 Months
measure: Percentage of Subjects With Serious Adverse Events at 36 Months (Post Approval) (Pulsar Stent Group).
timeFrame: 36 months
Other outcomes:
Locations:
city: Fremont
country: United States
state: California
city: New Haven
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Rockford
country: United States
state: Illinois
city: Munster
country: United States
state: Indiana
city: Houma
country: United States
state: Louisiana
city: Lansing
country: United States
state: Michigan
city: Saginaw
country: United States
state: Michigan
city: Wyoming
country: United States
state: Michigan
city: Ypsilanti
country: United States
state: Michigan
city: Tupelo
country: United States
state: Mississippi
city: Kansas City
country: United States
state: Missouri
city: Ridgewood
country: United States
state: New Jersey
city: Bronx
country: United States
state: New York
city: New York
country: United States
state: New York
city: Gastonia
country: United States
state: North Carolina
city: High Point
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Camp Hill
country: United States
state: Pennsylvania
city: Doylestown
country: United States
state: Pennsylvania
city: Langhorne
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Greenville
country: United States
state: South Carolina
city: Rock Hill
country: United States
state: South Carolina
city: Kingsport
country: United States
state: Tennessee
city: Amarillo
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: McKinney
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Waco
country: United States
state: Texas
city: Montreal
country: Canada
city: Toronto
country: Canada
Study officials:
affiliation: University of Toledo
name: Mark Burket, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burket MW, Brodmann M, Metzger C, Tan K, Jaff MR. Twelve-Month Results of the Nitinol Astron Stent in Iliac Artery Lesions. J Vasc Interv Radiol. 2016 Nov;27(11):1650-1656.e1. doi: 10.1016/j.jvir.2016.06.008. Epub 2016 Aug 16.