The XLIMUS-DES in Very Complex Lesions

Chronic Total Occlusion of Coronary Artery Clinical Trial

Official title:

Performance of the XLIMUS Sirolimus-eluting Coronary Stent In Very Complex Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02360020
• Other study ID #: NCTCM03
• Status: Completed
• Phase: Phase 4
• First received: February 2, 2015
• Last updated: May 9, 2016
• Start date: August 2014
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Clinica Mediterranea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

All consecutive patients who will undergo elective PCI in native coronary arteries at the Clinica Mediterranea (Naples, Italy) will be considered for eligility. Study participants wiil require to have symptomatic ischemic heart disease attributable to critical (that is, >70% visual estimate) stenotic lesions of native coronary arteries. Inclusion criteria in this pilot study are 1) chronic total occlusion (CTO), 2) severe target vessel calcification, and 3) severe target vessel tortuosity. CTO is defined as the presence of TIMI 0 flow within the occluded segment and angiographic or clinical evidence or high likelihood 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 it satisfies the following criteria: one or more bends of 90° or more, or three or more bends of 45-90° proximal to the diseased segment.

200 patients will be enrolled into the study. Stents will be implanted according to current clinical practice. 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 will be electively performed with the Rotablator® system (Boston Scientific Corporation, Natick, MA, U.S.A.). Following stent implantation, postdilatation will be performed in all instances with a non-compliant balloon. All patients will receive aspirin 325 mg and clopidogrel (75 mg daily) before stent deployment, with a loading dose (600 mg of clopidogrel) given to patients not pretreated. All patients will receive 70 IU/Kg intra-arterial bolus of unfractionated heparin in order to achieve and activated clotting time >250 seconds. Glycoprotein IIb/IIIa inhibitors will be administered according to operator preference. Estimated glomerular filtration rate (eGFR) will be calculated by applying the Levey Modification of Diet in Renal Disease (MDRD) formula. Chronic kidney disease was defined as a eGFR <60 ml/min/1.73 m2 .

XLIMUS eluting-stent is made of cobalt chromium L 605 and the stent is available in a 6-, 8-, or 10-cell structure design (closed cell architecture). The struts thickness is 73µm. The 6-cell design is for stenting of coronary artery diameter of 2.25mm-2.50mm, 8-cell structure is used for stenting of 2.75-3.50 mm artery diameters, and the 10-cell is for larger artery diameter lesions (up to 5mm). The XLIMUS has an innovative hydrophilic-coated shaft and an extra-low tip profile (crossing profile = 0.90 mm) to access the most tortuous lesions. The highly biocompatible polylactid acid (PLLA) drug containing release matrix degrades smoothly and provides an optimal release kinetic profile. Within 30 days, about 70% of the anti-proliferative drug is distributed into the surrounding arterial tissue of the stent struts, ensuring a highly effective inhibition of smooth muscle cell migration and proliferation. Pharmacokinetic study result confirm sustained anti-proliferative drug efficacy up to 120 days.

The primary objective of the study is the assessment of the clinical performance of the XLILMUS 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 and MACE.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• chronic total occlusion (CTO)

• severe calcification

• severe tortuosity

Exclusion Criteria:

• coronary artery lesions non satisfying the inclusion criteria

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Chronic Total Occlusion of Coronary Artery
• Coronary Artery Disease
• Coronary Atherosclerosis Due to Calcified Coronary Lesion
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Italy	Clinica Mediterranea	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Clinica Mediterranea

Country where clinical trial is conducted

Italy, 

References & Publications (13)

Ashikaga T, Sakurai K, Satoh Y. Tools & Techniques: stent delivery in distal lesions. EuroIntervention. 2010 Nov;6(5):660-1. doi: 10.4244/EIJV6I5A109. — View Citation

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. — View Citation

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. — View Citation

Feldman T. Tricks for overcoming difficult stent delivery. Catheter Cardiovasc Interv. 1999 Nov;48(3):285-6. — View Citation

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. — View Citation

Gyöngyösi 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Inhospital, 30-day and 1-year MACE	Major adverse cardiac events included death of any cause, nonfatal myocardial infarction, and repeated revascularization by PCI or surgery occurring within 30-day and 1-year. Myocardial infarction was defined as the presence of pathological and new Q waves on an ECG or as an increase in creatine kinase-myocardial band level to >3 times the upper limit of normal (ULN). Periprocedural myocardial infarction was defined as an increase of troponin I =5 times ULN. Target lesion revascularization was defined as a clinically-driven repeat percutaneous coronary angioplasty or coronary artery bypass surgery. Stent thrombosis was defined according to the Academic Research Consortium definitions	1 year	Yes