An observational study in Coronary Artery Disease, sponsored by Clinica Mediterranea. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-05.
Sponsored by Clinica Mediterranea · Observational
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.
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.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's enrollment of 326 is close to the median of 320 across 1,687 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Clinica Mediterranea is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
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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.
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Exclusion Criteria:
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Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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all consecutive patients with de novo bifurcation lesions treated at the Clinica Mediterranea (Naples) and at the "Sapienza" University (Rome) were screened for potential inclusion in the present study. Inclusion angiographic criteria were: 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. Both protected and unprotected left main bifurcation lesions were allowed to be included, provided that all previous angiographic criteria were satisfied. Patients deemed eligible underwent AXXESS stent implantation
Device: AXXESS stent
The control group is represented by patients with coronary bifurcation lesions treated with conventional techniques and standard balloon expandable drud eluting stents. This group was found retrospectively through a propensity score matching.
Axxess stent is a conically-shaped, self-expanding nitinol stent, with a 0.006-inch strut thickness, specifically designed to preserve and to match the anatomy of the bifurcation at the carina level. The stent is coated with Biolimus A9™, a highly lipophilic, semi-synthetic sirolimus analogue, immersed in the biodegradable polylactic acid (PLA) applied primarily to the abluminal surface. PLA completely dissolves after 6 to 9 months.The stent has 3 radiopaque markers at the distal end and one at the proximal end to aid in the visibility and placement. The AxxessTM stent is 7 Fr guiding catheter or Sheathless Guiding Catheter compatible. During the study period, the AxxessTM stent was available in 3 different diameters (3.0, 3.5 and 4.0 mm) and lengths (9, 10 and 14 mm)
device success
successful deployment of the AxxessTM stent into the target lesion, without system failure or device-related complication.
Time frame: intraprocedural
No study locations are listed for this record.
The record gives a start of Apr 2012, a primary completion of Aug 2014 and a completion of Jun 2015. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Clinica Mediterranea