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First patient enrolled in the PIONEER trial!

Date:2015-04-26
 
“My first time experiece with BuMA Supreme is that the stent is very smooth and easy to pass to the lesion. The low crossing profile makes the device easy to implant. ”  
- Prof. Clemens von Birgelen

On 24th April, the first patient was enrolled for PIONEER trial by prof. Clemens von Birgelen (PI PIONEER trial) at Medisch Spectrum Twente, Enschede, the Netherlands. 

Prof. Clemens shared the details of the first case and his experience of implanting BuMA Supreme™ stent. 

‘A male patient of 57 years with stable angina pectoris, who underwent via the right radial artery a coronary angiography (CAG) after having an abnormal bicycle test. During CAG, FFR measurement of an intermediately narrowed mid right coronary artery was performed (FFR 0.90). In addition, a severely narrowed intermediate branch of the left coronary artery was detected. The patient indicated interest in participation in the PIONEER trial. Therefore, PCI of this lesion was scheduled on the following day, and the patient gave his informed consent. PCI was also performed via the right radial route. After pre-dilatation, a 3.0/15mm BuMA Supreme stent was implanted, which was finally post-dilated with a non-compliant balloon at high pressures. The angiographic result was nice with coronary flow grade TIMI 3, and the patient was free from chest pain and could be discharged on the next day.’

‘My first time experiece with BuMA Supreme™ is that the stent is very smooth and easy to pass to the lesion. The low crossing profile makes the device easy to implant. ’

Clemens von Birgelen

Pre PCI   After pre-dilatation
 
     
Directly after stenting
 (BuMA Supreme 3.0x15mm)
  After post-dilatation(final result)
 

With this successful first enrolment of PIONEER trial, we look forward to the next 167 patients!

 

Background PIONEER trial

The PIONEER trial is a prospective, randomized, multi-center First-in-man trial examining the safety and efficacy of BuMA Supreme toward Resolute integrity with de novo coronary artery stenosis.  In total, 13 centres from the Netherlands, Belgium, Spain and Portugal are participating. The trial is chaired by prof. Patrick Serruys where prof. Clemens von Birgelen (MST, Enschede, the Netherlands) and prof. Manel Sabaté (Clinic hospital Barcelona, Spain) are positioned as principal investigator. 

For more information, please visit: https://clinicaltrials.gov/ct2/show/NCT02236975?term=pioneer+cardiology&rank=1