The XLIMUS-DES in Very Complex Lesions

NCT02360020 | Completed Phase 4 DMC

• 1 other identifier: NCTCM03
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Stent delivery failure occurs in 4% of all percutaneous coronary interventions (PCI) and \>90% of these failures are due to vessel tortuosity and/or calcification. The XLIMUS eluting coronary stent (CARDIONOVUM GmbH, Bonn, Germany) is a new type of endovascular prostheses characterised by better mechanical properties than traditional DES. This is a prospective, non-randomized, single-center pilot study, aiming to evaluate the performance of the XLIMUS DES in severely complex coronary lesions in real-world clinical practice.

Conditions

Coronary Atherosclerosis Due to Calcified Coronary Lesion; Chronic Total Occlusion of Coronary Artery

Keywords

coronary stent; outcome

Outcome Measures

Primary Outcomes (1)

• Stent Performance

  The primary objective of the study was the assessment of the clinical performance of the XLIMUS DES, using the following criteria 1) device success, defined as the ability to insert the stent into the target lesion and the attainment of \<20% residual stenosis (by visual estimate), 2) lesion success, defined as attainment of \<20% residual stenosis of the target lesion using any percutaneous method, and 3) procedural success, defined as lesion success without any in-hospital Man 30-day MACE

  up to 1 month

Secondary Outcomes (1)

• Inhospital, 30-day and 1-year MACE

  1 year

Study Arms (1)

XLimus patients

EXPERIMENTAL

participants must have symptomatic ischemic heart disease attributable to critical (that is, \>70% visual estimate) stenotic lesions of native coronary arteries. Inclusion criteria are 1) chronic total occlusion (CTO), 2) severe calcification, and 3) severe tortuosity. CTO is defined as the presence of TIMI 0 flow within the occluded segment and angiographic or clinical evidence of an occlusion duration of ≥3 months. Calcification is defined severe when larger than 3x vessel diameter, and comprising the vessel wall totally in two perpendicular views. Tortuosity is defined severe when: one or more bends \>= 90°, or three or more bends of 45-90° proximal to the diseased segment.

Device: XLimus

Interventions

XLimus DEVICE

Techniques attempted for facilitating stent delivery in such a complex lesions are: maximize guide catheter support, optimize predilatation of the stenosis, use of a stiffer guidewire. Specific tricks include: a) buddy-wire; anchoring balloon; GuideLiner catheter. In case of severe calcification, rotational atherectomy was electively performed with the Rotablator® system (Boston Scientific Corporation, Natick, MA, U.S.A.). Following stent implantation, postdilatation is performed in all instances with a non-compliant balloon

XLimus patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• chronic total occlusion (CTO)
• severe calcification
• severe tortuosity

Sponsors & Collaborators

• Clinica Mediterranea: lead

Study Sites (1)

Clinica Mediterranea

Naples, Naples, 80121, Italy

Location

Related Publications (13)

• Nikolsky E, Gruberg L, Pechersky S, Kapeliovich M, Grenadier E, Amikam S, Boulos M, Suleiman M, Markiewicz W, Beyar R. Stent deployment failure: reasons, implications, and short- and long-term outcomes. Catheter Cardiovasc Interv. 2003 Jul;59(3):324-8. doi: 10.1002/ccd.10543.

  PMID: 12822150 BACKGROUND

• Feldman T. Tricks for overcoming difficult stent delivery. Catheter Cardiovasc Interv. 1999 Nov;48(3):285-6. doi: 10.1002/(sici)1522-726x(199911)48:33.0.co;2-3. No abstract available.

  PMID: 10525229 BACKGROUND

• Fernandes V, Kaluza GL, Godlewski B, Li G, Raizner AE. Novel technique for stent delivery in tortuous coronary arteries: report of three cases. Catheter Cardiovasc Interv. 2002 Apr;55(4):485-90. doi: 10.1002/ccd.10139.

  PMID: 11948896 BACKGROUND

• Ashikaga T, Sakurai K, Satoh Y. Tools & Techniques: stent delivery in distal lesions. EuroIntervention. 2010 Nov;6(5):660-1. doi: 10.4244/EIJV6I5A109. No abstract available.

  PMID: 21044922 BACKGROUND

• Kumar S, Gorog DA, Secco GG, Di Mario C, Kukreja N. The GuideLiner "child" catheter for percutaneous coronary intervention - early clinical experience. J Invasive Cardiol. 2010 Oct;22(10):495-8.

  PMID: 20944191 BACKGROUND

• Rieu R, Barragan P, Garitey V, Roquebert PO, Fuseri J, Commeau P, Sainsous J. Assessment of the trackability, flexibility, and conformability of coronary stents: a comparative analysis. Catheter Cardiovasc Interv. 2003 Aug;59(4):496-503. doi: 10.1002/ccd.10583.

  PMID: 12891615 BACKGROUND

• Schmidt W, Lanzer P, Behrens P, Topoleski LD, Schmitz KP. A comparison of the mechanical performance characteristics of seven drug-eluting stent systems. Catheter Cardiovasc Interv. 2009 Feb 15;73(3):350-60. doi: 10.1002/ccd.21832.

  PMID: 19085917 BACKGROUND

• Morice MC, Colombo A, Meier B, Serruys P, Tamburino C, Guagliumi G, Sousa E, Stoll HP; REALITY Trial Investigators. Sirolimus- vs paclitaxel-eluting stents in de novo coronary artery lesions: the REALITY trial: a randomized controlled trial. JAMA. 2006 Feb 22;295(8):895-904. doi: 10.1001/jama.295.8.895.

  PMID: 16493102 BACKGROUND

• Lohavanichbutr K, Webb JG, Carere RG, Solankhi N, Jarochowski M, D'yachkova Y, Dodek A. Mechanisms, management, and outcome of failure of delivery of coronary stents. Am J Cardiol. 1999 Mar 1;83(5):779-81, A9. doi: 10.1016/s0002-9149(98)00990-4.

  PMID: 10080438 BACKGROUND

• Cantor WJ, Lazzam C, Cohen EA, Bowman KA, Dolman S, Mackie K, Natarajan MK, Strauss BH. Failed coronary stent deployment. Am Heart J. 1998 Dec;136(6):1088-95. doi: 10.1016/s0002-8703(98)70168-1.

  PMID: 9842025 BACKGROUND

• Mortier P, De Beule M, Segers P, Verdonck P, Verhegghe B. Virtual bench testing of new generation coronary stents. EuroIntervention. 2011 Jul;7(3):369-76. doi: 10.4244/EIJV7I3A62.

  PMID: 21729840 BACKGROUND

• Gyongyosi M, Yang P, Khorsand A, Glogar D. Longitudinal straightening effect of stents is an additional predictor for major adverse cardiac events. Austrian Wiktor Stent Study Group and European Paragon Stent Investigators. J Am Coll Cardiol. 2000 May;35(6):1580-9. doi: 10.1016/s0735-1097(00)00570-2.

  PMID: 10807464 BACKGROUND

• Briguori C, Visconti G, Focaccio A, Donahue M. Performance of the XLIMUS sirolimus-eluting coronary stent in very complex lesions. Minerva Cardioangiol. 2014 Feb;62(1):1-8.

  PMID: 24500212 BACKGROUND

Study Officials

• Carlo Briguori, Md, PhD

  Clinica Mediterranea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Invasive Cardiology

Study Record Dates

• First Submitted: February 2, 2015
• First Posted: February 10, 2015
• Study Start: August 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: May 1, 2016
• Last Updated: May 10, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)