An interventional study of Pulsar Stent and LifeStent Flexstar Vascular Stent in Stent Restenosis and Intimal Hyperplasia, sponsored by Medical University of Vienna. Status unknown at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-20.
Sponsored by Medical University of Vienna · Not applicable, Interventional, and Treatment
The objective of the BIOFLEX-COF trial is to investigate differences in formation of intimal hyperplasia at one and two years after implantation of nitinol-stents with high vs. low COF in de-novo femoropopliteal occlusive lesions in patients with symptomatic peripheral arterial disease.
The BIOFLEX-COF trial is a prospective, randomized controlled trial. 80 subjects will be enrolled and randomly assigned to either a high COF group (LifeStent Vascular Stent) or low COF group (Pulsar).
Self-expanding nitinol stents must be oversized at least by a minimal amount to ensure contact with the vessel wall and prevent migration. Once the stent is deployed it exerts a continuous force upon the vascular wall, termed chronic outward force (COF). Data about COF and neointimal hyperplasia in humans are currently lacking. Some animal studies, though, found a markedly increased neointimal hyperplasia in stents with high oversizing and thus high COF. The objective of the BIOFLEX-COF trial is to investigate differences in formation of intimal hyperplasia at one and two years after implantation of nitinol-stents with high vs. low COF in de-novo femoropopliteal occlusive lesions in patients with symptomatic peripheral arterial disease.
The BIOFLEX-COF trial is a prospective, randomized controlled trial. 80 subjects will be enrolled and randomly assigned to either a high COF group (LifeStent Vascular Stent) or low COF group (Pulsar). Diameter of implanted stents will be measured at every two millimetres along the stent axis on DICOM images of the respective completion angiography using image processing software.
The scheduled time for recruitment is 2 years. There will be two follow-up evaluations at 12 and 24 months.
Primary endpoint is the amount of in-stent neointima at one year, assessed by contrast-enhanced CT angiography (CTA). Secondary objectives are the amount of in-stent neointima at two years, device- and procedure-related adverse events and target lesion revascularisation (TLR) rate.
In the control examinations stent diameter and true lumen diameter will be measured on DICOM images every two millimetres along the stent axis to quantify the relative amount of in-stent restenosis.
The present study is challenging in that it compares two different self-expanding nitinol-stents head-to-head against each other. To optimize the power of this study, both clinical TLR and binary re-stenosis at Colour flow Doppler Ultrasound were dropped as primary endpoints. Instead the amount of neointima inside the stent accessed by CTA was selected as outcome parameter.
The study differs further from similar previous trials in its generous inclusions criteria. This was done in effort to perform the trial on a patient sample that closely represents real-world patients of a specialised endovascular centre.
891 studies on the registry are indexed under Hyperplasia; 103 are open to participants now.
This study's enrollment of 86 is close to the median of 82 across 613 interventional studies indexed under Hyperplasia.
Browse Hyperplasia studies →Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient related:
Clinical:
Angiographic and Lesion Requirements (assessed intraoperatively):
Exclusion Criteria:
The low COF-group receives a thin-strut stent (Pulsar, Biotronik AG, Bülach, Switzerland) with minimal oversizing (according to manufacturer's Instructions For Use)
Device: Pulsar Stent
The high COF-group receives a stiffer-stent (Lifestent Flexstar, Bard Peripheral Vascular Inc., Tempe, AZ, USA) with maximal oversizing (according to manufacturer's Instructions For Use).
Device: LifeStent Flexstar Vascular Stent
Percutane transluminal stent angioplasty with a Pulsar Stent of the superficial femoral artery for the treatment of peripheral arterial occlusive disease.
Percutane transluminal stent angioplasty with a LifeStent Flexstar Vascular Stent of the superficial femoral artery for the treatment of peripheral arterial occlusive disease.
Amount of in-stent restenosis
Mean amount of in-stent restenosis in percent along the stent axis at one and two years post-procedure.
Time frame: one and two years post-procedure
Adverse Events ISO 14155:2011
Adverse Events ISO 14155:2011
Time frame: within two years post-procedure
Target lesion revascularisation (TLR)
In patients with TLR the amount of in-stent restenosis will be assessed at the time of TLR.
Time frame: within two years post-procedure
Plan to share: No
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Medical University of Vienna