Clinical trial NCT02486315: Treatment of Coronary ARtery bIfurcation Narrowing by AXxess Stent Implantation
Official title: Treatment of Coronary ARtery bIfurcation Narrowing by AXxess Stent Implantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: coronary bifurcation
coronary stent
Lead sponsor: Clinica Mediterranea
Sponsor class: OTHER
First posted: 2015-07-01
Enrollment: 326
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all consecutive patients with de novo bifurcation lesions treated at the Clinica Mediterranea (Naples) and at the "Umberto I" University (Rome) were screened for potential inclusion in the present study.

Brief summary: The Axxess™ Biolimus A9™ Eluting Coronary Bifurcation Stent System (AXXESS System; Biosensors, International, Morges, Switzerland) is a dedicated bifurcation stent, designed to cover the lesion at the level of the carina. Although deemed ideal for lesions involving only the proximal MV (1,0,0 according to Medina classification ref), this device may be used also in more complex bifurcation lesions when additional DES are required in the distal MV and/or in the SB. In the present registry the investigators report the performance and the efficacy of the self-expanding biolimus-eluting AxxessTM stent for the treatment of bifurcation lesions in a real-world population.

Detailed description: Despite a comprehensive understanding of the physiological and technical issues regarding the coronary bifurcations lesions, percutaneous coronary intervention (PCI) in this setting remains challenging. When compared with non-bifurcation lesions, treatment of bifurcation lesions is associated with increased adverse clinical events and inferior angiographic outcomes including procedural complications. This is due to several technical challenges, including both anatomical (proximal-to-distal vessel mismatch \[tapering\], angulation and calcification) and procedural (plaque shift, and side-branch \[SB\] closure) features. Current balloon-expandable drug-eluting stent (DES) have not been designed to treat the bifurcation lesions; in particular, the inability of DES to adequately scaffold and preserve the ostium of SB represents a the major reason of failure, because this is the most common site for restenosis. Recently a large variety of dedicated bifurcation stents have been developed in order to 1) provide an easier access to the SB and to scaffold more effectively its ostium, and 2) adapt to main vassel (MV) tapering, and to the bifurcation anatomy.

Eligibility criteria: Inclusion Criteria:

1. significant (≥70% diameter stenosis) bifurcation lesion;
2. MV reference diameter between 2.75 and 4.75 mm by visually estimated
3. SB reference diameter ≥2.25 mm by visual estimate;
4. bifurcation angle (between the distal MV and the SB) \<70° by visual estimate

Exclusion Criteria:

1. patients with contraindications to prolonged dual-antiplatelet therapy,
2. known sensitivity to "limus" compounds, stainless steel, titanium, or nickel;
3. inclusion in others studies on bifurcation lesions; and
4. all bifurcation lesions not satisfying the angiographic inclusion criteria reported above

Primary outcomes:
measure: device success
timeFrame: intraprocedural
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Clinica Mediterranea
name: Carlo Briguori, MD,PhD
role: PRINCIPAL_INVESTIGATOR
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