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Peripheral Artery DiseaseBIOFLEX-I EUNCT01661231

Study to Determine the Performance of the Astron and Pulsar-18 Stents in Europe

A study testing Astron/Pulsar-18 stent in people with Peripheral Artery Disease and Peripheral Vascular Disease, run by Biotronik AG at 7 sites in 4 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Astron/Pulsar-18 stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
456 participants
Where
7 sitesin 4 countries
Study dates
Oct 2012to Oct 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • Willingness to comply with study follow-up requirements.
  • Candidate for percutaneous transluminal angioplasty (PTA).
  • Life-style limiting claudication or rest pain with an ABI ≤ 0.9 (resting or exercise). Thigh or toe brachial index (TBI) may be used / performed if ABI is inadequate.
  • Written informed consent.
  • 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 target lesion per limb).
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  • 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 enrolment 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 with PTA and/or commercially-available stent just prior to treatment of the target lesion. Successful treatment is defined as no complications and less than 30% residual stenosis following intervention.

Who cannot join

  • 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).
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  • 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.
  • International Normalized Ratio (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 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.

Trial locations and contacts

7 sites in 4 countries.

7 sites in 4 countries

Belgium3 sites

  • Imelda Ziekenhuis

    Bonheiden

  • AZ St.-Blasius Hospital

    Dendermonde

  • Regionaal Ziekenhuis Heilig Hart Tienen

    Tienen

Other trials in Belgium

Germany2 sites

  • Klinikum Arnsberg, Karolinen Hospital Huesten

    Arnsberg

  • Universitätsklinikum Münster

    Münster

Other trials in Germany

Austria1 site

  • Medical University of Graz

    Graz

Other trials in Austria

Switzerland1 site

  • University Hospital of Bern

    Bern

Other trials in Switzerland

About this study

Official title: BIOTRONIK - The Treatment of Iliac and Femoral Atherosclerotic Lesions Using the Self-expanding Astron and Pulsar-18 Stents (BIOFLEX-I Europe)

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.

Being tested
Astron/Pulsar-18 stent
Keywords
Vascular intervention, Endovascular, Peripheral stent
Medical subject headings
Peripheral Arterial Disease, Peripheral Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Astron/Pulsar-18 stentDevice

    Peripheral Vascular Intervention

Study groups in NCT01661231
Study groupRoleWhat they receive
Investigational StentsExperimentalDevice: Astron/Pulsar-18 Stents Implantation of self-expanding, bare-metal, nitinol stents for treatment of peripheral artery disease.
Receives: Device: Astron/Pulsar-18 stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months

  2. 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.

    Measured: 30 days

  3. 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.

    Measured: 12 months

Secondary outcomes (15)

  1. 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

    Measured: 30 days

  2. 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.

    Measured: 12 months

  3. 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

    Measured: 12 months

  4. Secondary Endpoint for the Pulsar-18 Stent

    Evaluate the stent fracture rate for the Pulsar-18 stent group at 12 months post-index procedure.

    Measured: 12 months

  5. Secondary Endpoint for the Astron Stent

    Evaluate the primary patency rate for the Astron stent at 12 months post-index procedure.

    Measured: 12 months

  6. 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.

    Measured: 12 months

  7. 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.

    Measured: 12 months

  8. Secondary Endpoint for Both the Astron and Pulsar-18 Stents

    Evaluate the 30-day clinical success of the procedure.

    Measured: 30 days

  9. 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.

    Measured: 12 months

  10. 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.

    Measured: 12 months

  11. 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

    Measured: 30 days

  12. 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

    Measured: 12 months

  13. 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.

    Measured: 12 months

  14. 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.

    Measured: 12 months

  15. 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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionSep 2015
  4. Study completionOct 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
456 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01661231
Sponsor's protocol ID
C1106
Acronym
BIOFLEX-I EU
Status last verified
Feb 2017
First submitted
2 Aug 2012
Last updated
3 Feb 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Astron/Pulsar-18 stent in people with Peripheral Artery Disease and Peripheral Vascular Disease, run by Biotronik AG at 7 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Belgium, Germany, Austria, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Endpoint for the Astron Stent (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01661231.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2017.

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