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Clinical Trials in Germany / NCT04192747
Active, not recruiting Not applicable

The Elixir Bioadaptor vs. The Onyx Stent in De Novo Native Coronary Arteries

NCT04192747 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2020-12-16
Last updated
2025-03-24

Condition(s) studied

Coronary Artery DiseaseCoronary Artery StenosisCoronary DiseaseCoronary Stenosis

Investigational drug(s) / intervention(s)

Percutaneous Coronary Intervention

Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions

Study summary

The objective of this study is to verify the safety and efficacy of the investigational device (ELX1805J) for the treatment of ischemic heart disease due to de novo, native coronary artery lesions

Eligibility

Sex
ALL
Min age
20 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: General Inclusion Criteria Patients who meet all of the following criteria are eligible: 1. Patient must be ≥ 20 years of age. 2. Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or electrocardiogram (ECG) changes consistent with ischemia) 3. Patients who are able to take dual anti-platelet therapy for 1 year following the index procedure and anticoagulants prior to/during the index procedure. 4. The subject is an acceptable candidate for Percutaneous Transluminal Coronary Angioplasty (PTCA), stenting, and emergent Coronary Artery Bypass Graft (CABG) surgery. 5. The subject or subject's legally authorized representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board or Ethics Committee of the respective clinical site. 6. Women of childbearing potential with a negative pregnancy test within 7 days and women who are not pregnant or nursing 7. Patient must agree to undergo all clinical study required follow up visits, angiograms, and imaging testing 8. Patient must agree not to participate in any other clinical research study for a period of one year following the index procedure 9. Target lesion(s) must be de novo and located in a native coronary artery with a vessel mean diameter of ≥ 2.25 and ≤ 4.0 mm. 10. Target lesion(s) must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and \< 100% with a TIMI flow of \> 1. When two target lesions are treated, they must be located in separate major epicardial vessels 11. visually estimated target lesion length is ≤ 34mm mm and must be able to be covered by a single 14/15/18/23/28/32/38 mm ELX1805J stent and have at least 2 mm of healthy vessel on either side Or 12. The visually estimated target lesion length is ≤ 34mm mm and must be able to be covered by a single 15/18/22/30/34/38 mm ZES stent respectively and have at least 2 mm of healthy vessel on either side. 13. The lesion(s) must be successfully pre-dilated prior to enrollment Mandatory pre-dilatation includes the use of 2 orthogonal views to confirm lesion inclusion and exclusion criteria and successful pre-dilatation defined as balloon inflation without waist and a lumen diameter no less than 0.5 mm smaller than the vessel diameter. 14. Percutaneous intervention of lesions in a non-target vessel if: * Not part of a another clinical investigation * ≥ 30 days prior to the study index procedure * ≥ 6 months after the study index procedure (planned) 15. Percutaneous intervention of lesions located in the target vessel if: * Not part of a clinical investigation * ≥ 6 months prior to the study index procedure * \>12 months after the study index procedure (planned) * Previous intervention was distal to and \>10 mm from the target lesion Exclusion Criteria: 1. The patient was diagnosed with an acute myocardial infarction within the past 72 hours and the CK and CKMB have not returned to normal (or cTn \>15x ULN) and the patient is experiencing clinical symptoms indicative of ongoing ischemia 2. Patient has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, clopidogrel, prasugrel or ticagrelor, cobalt, nickel, chromium, molybdenum, PLLA polymers or contrast sensitivity that cannot be adequately pre-medicated 3. Patients with a history of allergic reaction or serious hypersensitivity to drugs exhibiting interactions with sirolimus, zotarolimus, everolimus, tacrolimus, temsirolimus, biolimus and other rapamycin, derivatives or analogues) or similar drugs 4. Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin or clopidogrel or other P2Y12 inhibitors. 5. Patient presenting with chronic (permanent) atrial or ventricular arrhythmia or current unstable ventricular arrhythmias 6. Patient has a known left ventricular ejection fraction (LVEF) \< 30% 7. Patient has received a heart or other organ transplant or is on a waiting list for any organ transplant 8. Patient has a malignancy that is not in remission. 9. Patient is receiving immunosuppression therapy other than steroids and has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.) 10. Patient is receiving chronic anticoagulation therapy (e.g., heparin, coumadin) that cannot be stopped and restarted according to local hospital standard procedures. 11. Patient has a platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3, a WBC of \< 3,000 cells/mm3, or documented or suspected to have cirrhosis of Child-Pugh ≥ Class B within 7 days before study procedure 12. Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5 mg/dL within 7 days before study procedure, or patient on dialysis) 13. Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions 14. Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months 15. Patient has had a significant GI or urinary bleed within the past six months 16. Patient has severe symptomatic heart failure (i.e., NYHA class IV) 17. Patient has a medical condition that precludes safe 6 French sheath insertion 18. Patient has other medical illness or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical study plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year) 19. Patient is already participating in another clinical research study which has not reached the primary endpoint (long-term follow-up is not an exclusion) 20. Other patients whom primary investigator or subinvestigator determined to be ineligible for this clinical study 21. Patients with bypass graft to the target vessel or lesion is located in a bypass graft 22. Patients with stent implanted within 10 mm of proximal or distal end of target lesion 23. Patients with a target lesion involving a bifurcation of which the side branch will be jailed by the struts and: * Side branch ≥ 2.5 mm in diameter, * Side branch requiring predilatation (including Kissing Balloon Technique), or * Side branch has an ostial lesion or lesion with \> 50% stenosis 24. Patients suspected or confirmed with the QCA analysis of having stenotic lesion of more than 50% in target vessel in addition to target lesion 25. Patients with target lesion in ostia located within 5 mm of origin of LAD, LCX or RCA 26. Patients with stenotic lesion in left main trunk 27. Patients with target lesion that is a chronic total occlusion (CTO) or ≤ TIMI 1 coronary flow in the target vessel 28. Patients with target vessel that contains thrombus as indicated in pre-procedure angiographic, IVUS or OCT images 29. Excessive tortuosity ≥ two 45° angles or extreme angulation (≥ 90°) proximal to or within the target lesion 30. Patients with target vessel that has moderate to severe calcification that prevents complete angioplasty balloon (POBA with non-compliant balloon, or scoring balloon,) inflation or requires other devices such as rotational atherectomy, rotoblator. 31. Patients with dissection of Grade A or B that cannot be covered (including 2mm distal to the dissection) with a single study device or with dissection of Grade C or higher 32. Patients with 2 or more target lesions on 1 branch or target lesions on 3 branches that need to be treated during study procedure 33. Target lesion involves a myocardial bridge

Primary outcome measure(s)

Trial sites (36)

FacilityCityRegionStatus
AZ Middelheim Hospital Antwerp Belgium
AZ Sint Jan Brugge Bruges Belgium
Ziekenhuis Oost-Limburg Genk Belgium
Universitaire Ziekenhuizen Leuven Leuven Belgium
Kerkhoff Klinik GmbH Bad Nauheim Germany
Segeberger Kliniken GmbH Bad Segeberg Germany
REGIOMED Klinikum Coburg Coburg Germany
St. Johannes Hospital Dortmund Germany
Universitatsklinikum Erlangen Erlangen Germany
Elisabeth Krankenhaus Essen Essen Germany
MVZ CCB Frankfurt Frankfurt Germany
Universitatsklinikun Giessen Giessen Germany
Universitätsklinikum Jena Jena Germany
UKSH Kiel Klinik Kiel Germany
Universitätsmedizin-Mainz Mainz Germany
Krankenhaus der barmherzigen Bruder Trier Germany
Kokura Memorial Hospital Kitakyushu Fukuoka
Shinkoga Hospital Kurume Fukuoka
Sapporo Higashi Tokushukai Hospital Sapporo Hokkaido
Takahashi Hospital Tsuchiura Ibaraki
Tsuchiura Kyodo Hospital Tsuchiura Ibaraki
Tenyokai Central Hospital Kagoshima Kagoshima-ken
Shonan Kamakura General Hospital Kamakura Kanagawa
Kanto Rosai Hospital Kawasaki-shi Kanagawa
Yokohama City Eastern Hospital Yokohama Kanagawa
Kumamoto Rousai Hospital Kumamoto Kumamoto
Miyazaki Medical Association Hospital Miyazaki Miyazaki
Oumi Hachiman City General Medical Center Hachiman Shiga
Cardiovascular Reaearch Institute Tokyo Japan
Teikyo University Hospital Tokyo Japan
Auckland City Hospital Auckland New Zealand
Middlemore Clinical Trials Trust Auckland New Zealand
Waikato Hospital Auckland New Zealand
Christchurch Hospital Christchurch New Zealand
Dunedin Hospital Dunedin New Zealand
North Shore Hospital Takapuna New Zealand

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04192747 on ClinicalTrials.gov ↗ ← All trials in Germany