BIOFLEX-I EU is the European arm of the BIOFLEX-I IDE study (NCT01319812). Data from BIOFLEX-I EU will be pooled with data in the IDE. The objective of this study is to separately demonstrate the clinical performance of BIOTRONIK's Astron and Pulsar-18 stents in the European arm of the BIOFLEX-I IDE (NCT01319812). The Pulsar-18 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
456
Peripheral Vascular Intervention
Medical University of Graz
Graz, Austria
Imelda Ziekenhuis
Bonheiden, Belgium
AZ St.-Blasius Hospital
Dendermonde, Belgium
Regionaal Ziekenhuis Heilig Hart Tienen
Tienen, Belgium
Klinikum Arnsberg, Karolinen Hospital Huesten
Arnsberg, Germany
Universitätsklinikum Münster
Münster, Germany
University Hospital of Bern
Bern, Switzerland
Primary Endpoint for the Astron Stent
A composite of the rate of procedure- or stent-related major adverse events (MAEs) at 12 months post-index procedure. The MAE rate includes 30-day mortality, along with 12-month rates of target lesion revascularization (TLR) and index limb amputation.
Time frame: 12 months
Clinical Primary Endpoint for the Pulsar-18 Stent
Freedom from procedure- or stent-related MAEs at 30 days post-index procedure. The MAE rate includes mortality, TLR and index limb amputation.
Time frame: 30 days
Performance Primary Endpoint for the Pulsar-18 Stent
Primary patency rate (defined as freedom from more than 50% restenosis) at 12 months post-index procedure, as measured by duplex ultrasound.
Time frame: 12 months
Secondary Endpoint for the Pulsar-18 Stent
Contribution of the individual rates of mortality, TLR and index limb amputation at 30 days post-index procedure to the primary clinical endpoint for the Pulsar-18 stent group
Time frame: 30 days
Secondary Endpoint for the Astron Stent
Contribution of the individual rates of 30-day mortality and 12-month TLR and index limb amputation rates to the primary endpoint for the Astron stent.
Time frame: 12 months
Secondary Endpoint for the Pulsar-18 Stent
Evaluate the MAE rate of the Pulsar-18 stent group at 12 months post-index procedure, along with the contribution the individual rates of 30-day mortality and 12-month TLR and index limb amputation rates to the overall MAE rate
Time frame: 12 months
Secondary Endpoint for the Pulsar-18 Stent
Evaluate the stent fracture rate for the Pulsar-18 stent group at 12 months post-index procedure.
Time frame: 12 months
Secondary Endpoint for the Astron Stent
Evaluate the primary patency rate for the Astron stent at 12 months post-index procedure.
Time frame: 12 months
Secondary Endpoint for Both the Astron and Pulsar-18 Stents
Evaluate the primary assisted patency rate for the Astron stent and the Pulsar-18 stent group at 12 months post-index procedure.
Time frame: 12 months
Secondary Endpoint for Both the Astron and Pulsar-18 Stents
Evaluate the secondary patency rate for the Astron stent and the Pulsar-18 stent group at 12 months post-index procedure.
Time frame: 12 months
Secondary Endpoint for Both the Astron and Pulsar-18 Stents
Evaluate the 30-day clinical success of the procedure.
Time frame: 30 days
Secondary Endpoint for Both the Astron and Pulsar-18 Stents
Compare the ABI measurement(s) of the treated limb(s) between baseline and 12 months post-index procedure.
Time frame: 12 months
Secondary Endpoint for Both the Astron and Pulsar-18 Stents
Compare the scores on the Walking Impairment Questionnaire between baseline and 12 months post-index procedure.
Time frame: 12 months
Secondary Endpoint for Both the Astron and Pulsar-18 Stents
Evaluate the acute procedural success of the Astron stent and the Pulsar-18 stent group
Time frame: 30 days
Secondary Endpoint for Both the Astron and Pulsar-18 stents
Evaluate the rates of all individual adverse event types that are not included in the primary endpoint analyses for the Astron and Pulsar-18 stents
Time frame: 12 months
Comparison of Endpoints Results Between Short and Long Lesions for Pulsar-18 Stent
Compare the primary and secondary endpoint results between evaluable subjects in the Pulsar-18 stents with lesions from 20 mm to 140 mm in length and evaluable subjects with lesions from 141 mm to 190 mm in length.
Time frame: 12 months
Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar-18 Stents
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-18 stent group.
Time frame: 12 months
Secondary Endpoint for Both the Astron and Pulsar-18 Stents
Compare the distance walked during the six-minute walk test between baseline and 12 months post-index procedure
Time frame: 12 months
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