Treatment of Coronary ARtery bIfurcation Narrowing by AXxess Stent Implantation (CARINAX)

March 2, 2024 updated by: Carlo Briguori, Clinica Mediterranea
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

326

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Device: 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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
device success
Time Frame: intraprocedural
successful deployment of the AxxessTM stent into the target lesion, without system failure or device-related complication.
intraprocedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinica Mediterranea

Investigators

  • Principal Investigator: Carlo Briguori, MD,PhD, Clinica Mediterranea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

June 24, 2015

First Submitted That Met QC Criteria

June 30, 2015

First Posted (Estimated)

July 1, 2015

Study Record Updates

Last Update Posted (Actual)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 2, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCTC005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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