Suspended

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Astron/Pulsar-18 stent

Device
Who is being recruted

Arterial Occlusive Diseases+4

+ Arteriosclerosis

+ Cardiovascular Diseases

Over 18 Years
+42 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: October 2012
See protocol details

Summary

Principal SponsorBiotronik AG
Last updated: February 3, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01661231
Principal SponsorBiotronik AG
Last updated: February 3, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

456 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arterial Occlusive DiseasesArteriosclerosisCardiovascular DiseasesVascular DiseasesAtherosclerosisPeripheral Vascular DiseasesPeripheral Arterial Disease

Criteria

17 inclusion criteria required to participate
Age >= 18 years
Angiographic evidence of >= 70% stenosis or occlusion (operator visual assessment)
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
Candidate for percutaneous transluminal angioplasty (PTA)
Show More Criteria
25 exclusion criteria prevent from participating
Additional percutaneous interventional procedures (cardiac and/or peripheral) planned within 30 days after the index procedure
Any medical condition, that in the opinion of the investigator, poses an unacceptable risk for implant of a stent according to the study indications
Concomitant renal failure with serum creatinine level > 2.5 mg/dL
International Normalized Ratio (INR) >= 1.6
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Medical University of Graz

Graz, AustriaOpen Medical University of Graz in Google Maps

Imelda Ziekenhuis

Bonheiden, Belgium

AZ St.-Blasius Hospital

Dendermonde, Belgium

Regionaal Ziekenhuis Heilig Hart Tienen

Tienen, Belgium
Suspended7 Study Centers