Treatment of Coronary ARtery bIfurcation Narrowing by AXxess Stent Implantation

NCT ID: NCT02486315

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 326 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2015-06-30

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.

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

AXXESS stent

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

AXXESS stent

Intervention Type: DEVICE

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)

Control group

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.

No interventions assigned to this group

Interventions

AXXESS stent

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)

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinica Mediterranea

OTHER

Sponsor Role: lead

Responsible Party

Carlo Briguori

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carlo Briguori, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Clinica Mediterranea

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Other Identifiers

NCTC005

Identifier Type: -

Identifier Source: org_study_id