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

NCT01661231 | Unknown

• 1 other identifier: C1106
• Study Type: interventional
• Target: 456
• Locations: 4 countries
• Sites: 7

Brief 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). 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.

Conditions

Peripheral Artery Disease; Peripheral Vascular Disease

Keywords

Vascular intervention; Endovascular; Peripheral stent

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  12 months

Secondary Outcomes (15)

• Secondary Endpoint for the Pulsar-18 Stent

  30 days

• Secondary Endpoint for the Astron Stent

  12 months

• Secondary Endpoint for the Pulsar-18 Stent

  12 months

• Secondary Endpoint for the Pulsar-18 Stent

  12 months

• Secondary Endpoint for the Astron Stent

  12 months

Study Arms (1)

Investigational Stents

EXPERIMENTAL

Device: Astron/Pulsar-18 Stents Implantation of self-expanding, bare-metal, nitinol stents for treatment of peripheral artery disease.

Device: Astron/Pulsar-18 stent

Interventions

Astron/Pulsar-18 stent DEVICE

Peripheral Vascular Intervention

Investigational Stents

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.
• International Normalized Ratio (INR) ≥ 1.6

Sponsors & Collaborators

• Biotronik AG: lead
• Biotronik, Inc.: collaborator

Study Sites (7)

Medical University of Graz

Graz, Austria

Location

Imelda Ziekenhuis

Bonheiden, Belgium

Location

AZ St.-Blasius Hospital

Dendermonde, Belgium

Location

Regionaal Ziekenhuis Heilig Hart Tienen

Tienen, Belgium

Location

Klinikum Arnsberg, Karolinen Hospital Huesten

Arnsberg, Germany

Location

Universitätsklinikum Münster

Münster, Germany

Location

University Hospital of Bern

Bern, Switzerland

Location

Related Links

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

MeSH Terms

Conditions

Peripheral Arterial Disease; Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Marianne Brodmann, MD

  Medical University of Graz, Graz, Austria

  PRINCIPAL INVESTIGATOR

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 2, 2012
• First Posted: August 9, 2012
• Study Start: October 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: October 1, 2018
• Last Updated: February 3, 2017

Record last verified: 2017-02

Locations

DE (2); BE (3); AU (1); CH (1)