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The XLIMUS-DES in Very Complex Lesions

NCT02360020 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2016-05-10

No results posted yet for this study

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

Interventions

DEVICE

XLimus

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

Sponsors & Collaborators

  • Clinica Mediterranea

    lead OTHER

Principal Investigators

  • Carlo Briguori, Md, PhD · Clinica Mediterranea

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-12-31
Completion
2016-05-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02360020 on ClinicalTrials.gov