BIOFLEX-I

BIOFLEX-I

NCT01319812

Prospective, international, multi-center, investigational device exemption trial evaluating BIOTRONIK Astron nitinol self-expanding stent for iliac arteries

Conclusion

  • At 12 months results show primary patency (PP) rates of 89.8% (115/1281 patients) and freedom from Target Lesion Revascularization (FTLR) rates of 98.6% (144/146 2 patients).
  • At 12 months, major adverse event (MAE) rate is 2.1%, showing safety of the treatment and meeting the primary endpoint.
  • Improvement in ankle brachial index (ABI) shows clinical benefit with mean change from baseline to 12 months of 0.23 ± 0.19.
  • The Astron stent is a viable option for the treatment of patients with iliac artery disease.

Patient Demographics and Lesion Characteristics

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Picture shows patient demographics
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Picture shows lesion characteristics

Study Design

Prospective, international, multi-center, investigational device exemption trial evaluating BIOTRONIK Astron nitinol self-expanding stent for iliac arteries, conducted at 30 centers in the US, Canada and Europe.

  • Number of patients (n): 161
  • Principal investigators: Dr. Mark Burket, University of Toledo, Ohio, United States, and Dr. Marianne Brodmann, University of Graz, Austria
  • Primary endpoint: composite rate of procedure- or stent-related MAEs at 12 months, post-index procedure (30-day mortality, 12-month clinically-driven TLR and index-limb amputation)
  • Secondary clinical endpoints (selected): components of MAE, PP at 12 months assessed by DUS (PSVR > 2.4) 3, acute procedural success, ankle-brachial index (ABI), walking impairment questionnaire (WIQ) and 6-minute walk test change from baseline to 12 months
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Picture shows study design

Primary Endpoint Results

MAE rate composite and components at 12 months

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Picture shows study results

Downloads


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Picture shows Astron stent

Vascular Intervention

Self-Expanding StentPull-back delivery system for simple stent deployment

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Picture shows Astron Pulsar

Vascular Intervention

Self-Expanding StentS-articulating connecting bars and peak-to-valley design for multi-directional flexibility


Source:
BIOFLEX-I 12m, Burket M. Presented at CRT conference 2015.

1ITT (intention to treat population) with DUS (duplex ultra sound).
2 ITT completed subjects.
3 Loss of patency defined as or based on a clinically indicated TLR with angiographic evidence of > 50% stenosis.
4 Two-sided test for difference equal to zero 5 Test for difference equal to zero (Student's t-test, two-sided and Wilcoxon Test, two-sided)
6 Subjects with paired data (baseline and 12 months)

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