Treatment of Coronary ARtery bIfurcation Narrowing by AXxess Stent Implantation

NCT02486315 | Completed DMC

• 1 other identifier: NCTC005
• Study Type: observational
• Target: 326
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Artery Disease

Keywords

coronary bifurcation; coronary stent

Outcome Measures

Primary Outcomes (1)

• device success

  successful deployment of the AxxessTM stent into the target lesion, without system failure or device-related complication.

  intraprocedural

Study Arms (2)

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

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.

Interventions

AXXESS stent 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)

AXXESS stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• patients with contraindications to prolonged dual-antiplatelet therapy,
• known sensitivity to "limus" compounds, stainless steel, titanium, or nickel;

Sponsors & Collaborators

• Clinica Mediterranea: lead

Related Publications (12)

• Latib A, Colombo A. Bifurcation disease: what do we know, what should we do? JACC Cardiovasc Interv. 2008 Jun;1(3):218-26. doi: 10.1016/j.jcin.2007.12.008.

  PMID: 19463303 BACKGROUND

• Wykrzykowska JJ, Grundeken MJ, Stankovic G, Di Mario C. Is there a need for dedicated devices? EuroIntervention. 2015;11 Suppl V:V139-42. doi: 10.4244/EIJV11SVA31.

  PMID: 25983149 BACKGROUND

• Grube E, Buellesfeld L, Neumann FJ, Verheye S, Abizaid A, McClean D, Mueller R, Lansky A, Mehran R, Costa R, Gerckens U, Trauthen B, Fitzgerald PJ. Six-month clinical and angiographic results of a dedicated drug-eluting stent for the treatment of coronary bifurcation narrowings. Am J Cardiol. 2007 Jun 15;99(12):1691-7. doi: 10.1016/j.amjcard.2007.01.043. Epub 2007 May 7.

  PMID: 17560877 BACKGROUND

• Buysschaert I, Dubois CL, Dens J, Ormiston J, Worthley S, McClean D, Ottervanger JP, Meredith I, Uren N, Wijns W, Whitbourn R, Mehran R, Lansky AJ, Bichalska M, Meis S, Verheye S. Three-year clinical results of the Axxess Biolimus A9 eluting bifurcation stent system: the DIVERGE study. EuroIntervention. 2013 Sep;9(5):573-81. doi: 10.4244/EIJV9I5A93.

  PMID: 24058075 BACKGROUND

• Hasegawa T, Ako J, Koo BK, Miyazawa A, Sakurai R, Chang H, Dens J, Verheye S, Grube E, Honda Y, Fitzgerald PJ. Analysis of left main coronary artery bifurcation lesions treated with biolimus-eluting DEVAX AXXESS plus nitinol self-expanding stent: intravascular ultrasound results of the AXXENT trial. Catheter Cardiovasc Interv. 2009 Jan 1;73(1):34-41. doi: 10.1002/ccd.21765.

  PMID: 19089934 BACKGROUND

• Garcia E, Unzue Vallejo L, Rodriguez-Rodrigo FJ. Placement of a single Axxess stent as new treatment strategy for Medina 1,0,0 left main stem bifurcation lesion. J Invasive Cardiol. 2014 Apr;26(4):E45-7.

  PMID: 24717281 BACKGROUND

• Louvard Y, Thomas M, Dzavik V, Hildick-Smith D, Galassi AR, Pan M, Burzotta F, Zelizko M, Dudek D, Ludman P, Sheiban I, Lassen JF, Darremont O, Kastrati A, Ludwig J, Iakovou I, Brunel P, Lansky A, Meerkin D, Legrand V, Medina A, Lefevre T. Classification of coronary artery bifurcation lesions and treatments: time for a consensus! Catheter Cardiovasc Interv. 2008 Feb 1;71(2):175-83. doi: 10.1002/ccd.21314.

  PMID: 17985377 BACKGROUND

• Lassen JF, Holm NR, Stankovic G, Lefevre T, Chieffo A, Hildick-Smith D, Pan M, Darremont O, Albiero R, Ferenc M, Louvard Y. Percutaneous coronary intervention for coronary bifurcation disease: consensus from the first 10 years of the European Bifurcation Club meetings. EuroIntervention. 2014 Sep;10(5):545-60. doi: 10.4244/EIJV10I5A97.

  PMID: 25256198 BACKGROUND

• Medina A, Suarez de Lezo J, Pan M. [A new classification of coronary bifurcation lesions]. Rev Esp Cardiol. 2006 Feb;59(2):183. No abstract available. Spanish.

  PMID: 16540043 BACKGROUND

• Noguchi T, Miyazaki MD S, Morii I, Daikoku S, Goto Y, Nonogi H. Percutaneous transluminal coronary angioplasty of chronic total occlusions. Determinants of primary success and long-term clinical outcome. Catheter Cardiovasc Interv. 2000 Mar;49(3):258-64. doi: 10.1002/(sici)1522-726x(200003)49:33.0.co;2-l.

  PMID: 10700054 BACKGROUND

• Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction; Katus HA, Lindahl B, Morrow DA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasche P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S. Third universal definition of myocardial infarction. Circulation. 2012 Oct 16;126(16):2020-35. doi: 10.1161/CIR.0b013e31826e1058. Epub 2012 Aug 24. No abstract available.

  PMID: 22923432 BACKGROUND

• Behan MW, Holm NR, Curzen NP, Erglis A, Stables RH, de Belder AJ, Niemela M, Cooter N, Chew DP, Steigen TK, Oldroyd KG, Jensen JS, Lassen JF, Thuesen L, Hildick-Smith D. Simple or complex stenting for bifurcation coronary lesions: a patient-level pooled-analysis of the Nordic Bifurcation Study and the British Bifurcation Coronary Study. Circ Cardiovasc Interv. 2011 Feb 1;4(1):57-64. doi: 10.1161/CIRCINTERVENTIONS.110.958512. Epub 2011 Jan 4.

  PMID: 21205942 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Carlo Briguori, MD,PhD

  Clinica Mediterranea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 24, 2015
• First Posted: July 1, 2015
• Study Start: April 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: June 1, 2015
• Last Updated: March 5, 2024

Record last verified: 2024-03