A Phase 4 interventional study of XLimus in Coronary Atherosclerosis Due to Calcified Coronary Lesion and Chronic Total Occlusion of Coronary Artery, sponsored by Clinica Mediterranea. Completed at 1 site in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-05-10.
Sponsored by Clinica Mediterranea · Phase 4, Interventional, and Treatment
Among 302 studies in Coronary Artery Disease with a site in Italy — 48 open to participants now, 71 under way, 7 of them phase 3. Coronary Artery Disease · Italy.
Among the 302 studies in Coronary Artery Disease with a site in Italy, this one is the 105th largest by enrollment of the 189 interventional ones, is one of 20 that started in 2014, is one of 57 in phase 4, and was the 129th registered.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's enrollment of 200 is above the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →48 of the 302 studies in Coronary Artery Disease with a site in Italy are open now, in 12 countries. Each count lists the studies.
Of the 588 Coronary Artery Disease studies recruiting now, 402 (68%) set no upper age limit and 68 (12%) stop at 75 or younger; 38 take children under 18; 47 take healthy volunteers.
This study: 18 Years to 90 Years · all sexes · no healthy volunteers.
The full table on the hub →302 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 20 started in 2014.
Median enrollment 290 across the 189 interventional studies, 400 across the 113 observational. Of the 151 that completed or were terminated, 35 (23%) have results posted.
101 of 302 have an industry lead sponsor. The 10 most frequent:
Clinica Mediterranea is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Clinica Mediterranea has 2 studies filed under Coronary Artery Disease — fewer than ten, so there is no comparison to draw.
12 of the studies in Coronary Artery Disease with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06410690Centro Cardiologico MonzinoTrustworthy, Integrated Artificial Intelligence Tools for Predicting High-risk CORonary PlaqueS | 2026-11-30 |
| NCT04604782GE HealthcareA Study to Evaluate the Safety and Pharmacokinetics of Regadenoson in Pediatric Patients | 2026-12 |
| NCT06321757Fundación EPICPREVAIL Paclitaxel-coated Balloon in Small Coronary Disease and High-bleeding Risk Patients | 2026-12-30 |
| NCT07817524Fondazione Policlinico Universitario Agostino Gemelli IRCCSClinical Outcome of Coronary Artery Bypass Graft Surgery Versus Percutaneous Coronary Intervention in Patients With Severe Left Ventricular Disfunction (CROWN) | 2026-12-31 |
| NCT07291609Azienda Ospedaliera "Sant'Andrea"Microplastics and Nanoplastics in Patients With Chronic Coronary Syndromes | 2026-12-31 |
Among the 302 studies in Coronary Artery Disease with a site in Italy, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
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
Time frame: up to 1 month
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
Time frame: 1 year
Plan to share: Yes — We plan to present and publish the results in an international journal of interventional cardiology
The record gives a start of Aug 2014, a primary completion of Dec 2015 and a completion of May 2016. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Clinica Mediterranea