- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02086045
Elixir Medical Clinical Evaluation of the DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System - The DESolve Nx Trial
A NON-RANDOMIZED, CONSECUTIVE ENROLLMENT EVALUATION OF THE DESolve® NOVOLIMUS ELUTING BIORESORBABLE CORONARY SCAFFOLD SYSTEM IN THE TREATMENT OF PATIENTS WITH DE NOVO NATIVE CORONARY ARTERY LESIONS
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Antwerp, Belgium, 2020
- AZ Middelheim Hospital
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Genk, Belgium, B-3600
- St. - Jan Ziekenhuis Z.O.L.
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Sao Paulo, Brazil, 0401210
- Instituto Dante Pazzanese
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Uberlandia, Brazil, 38400-368
- ICT / Instituto Do Coracao Do Triangulo Mineiro
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Aarhus N, Denmark, 8200
- Aarhus University Hospital, Skejby
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Berlin, Germany, 12203
- Charite - Campus Benjamin Franklin
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Hamburg, Germany, 22527
- Universitäres Herz- und Gefäßzentrum
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Auckland, New Zealand, 1023
- Auckland City Hospital
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Auckland, New Zealand, 1023
- Mercy Angiography Unit
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Auckland, New Zealand, 0622
- North Shore Hospital
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Dąbrowa Górnicza, Poland, 43-300
- Polsko-Amerykańskie Kliniki Serca
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Krakow, Poland, 31-501
- Jagiellonian University
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Krakow, Poland, 31-202
- Centrum Interwencyjnego Leczenia Chorób Serca
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patient must be at least 18 years of age and for the 35-patient subset, patients must be over the age of 50
- Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the DESolve Nx Novolimus Eluting BCSS and he/she provides written informed consent, as approved by the appropriate Ethics Committee of the respective clinical site, prior to any clinical study related procedure
- 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)
- Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery
- Patient must agree to undergo all clinical study required follow-up visits, angiograms, and as applicable, IVUS, OCT, MSCT and coronary vasomotion testing
- Patient must agree not to participate in any other clinical study for a period of two years following the index procedure
Angiographic Inclusion Criteria:
Target lesion must be located in a native coronary artery with a nominal vessel diameter of between 2.75 and 3.5 mm assessed by online QCA
- Target lesion must measure ≤ 14 mm in length
- Target lesion must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and < 90% with a TIMI flow of ≥ 1
Percutaneous intervention of lesions in the target vessel if:
- Not part of a clinical investigation
- ≥ 6 months prior to the study index procedure
- ≥ 9 months after the study index procedure (planned)
- Previous intervention was distal to and >10mm from the target lesion
Exclusion Criteria:
- Patient has a known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure and CK and CK-MB have not returned within normal limits at the time of procedure
- Patient is currently experiencing clinical symptoms consistent with AMI
- Patient requires the use of any rotablator intervention during the index procedure
- Patient has current unstable arrhythmias
- Patient has a known left ventricular ejection fraction (LVEF) < 30%
- Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant
- Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure
- Patient is receiving immunosuppression therapy and has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.)
- Patient is receiving chronic anticoagulation therapy (e.g., heparin, coumadin) that cannot be stopped and restarted according to local hospital standard procedures.
- Patient has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, both clopidogrel and ticlopidine, Novolimus, PLLA polymers or contrast sensitivity that cannot be adequately pre-medicated
- Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin or clopidogrel
- 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 liver disease.
- Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5 mg/dL, or patient on dialysis)
- Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
- Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months
- Patient has had a significant GI or urinary bleed within the past six months
- Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion
- Patient has other medical illness (e.g., cancer or congestive heart failure) 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)
- Patient is already participating in another clinical study
- Women of childbearing potential who have not undergone surgical sterilization or are not post-menopausal (defined as amenorrheic for at least one year) as well as women who are pregnant or nursing
- Patient is unable to give their consent, is legally incompetent, or is institutionalized by virtue of an order issued by the courts or other authority
Angiographic Exclusion Criteria
Target lesion(s) meets any of the following criteria:
- Aorto-ostial location
- Left main location
- Located within 5 mm of the origin of the LAD or LCX
- Located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft
- Lesion involving a side branch >2mm in diameter or bifurcation
- Previous placement of a scaffold proximal to or within 10 mm of the target lesion
- Total occlusion (TIMI flow 0), or TIMI flow < 1
- Excessive tortuosity proximal to or within the lesion
- Angulation (≥ 45o) proximal to or within the lesion
- Calcification moderate or heavy
- Previous intervention restenosis
- The target vessel contains visible thrombus
- Another clinically significant lesion (>40%) is located in the same major epicardial vessel as the target lesion
- Patient has a high probability that a procedure other than pre-dilatation and scaffolding and (if necessary) post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon or brachytherapy)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: DESolve Novolimus Eluting Bioresorbable Coronary Scaffold
DESolve Scaffold
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percutaneous coronary
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinically-indicated major adverse cardiac events (MACE)
Time Frame: 6 months
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cardiac death, target vessel MI, clinically indicated TLR
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6 months
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Late Lumen Loss
Time Frame: 6 month
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MLD post procedure - MLD at follow-up
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6 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Major Adverse Cardiac Events
Time Frame: 1 month
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cardiac death, target vessel MI, clinically indicated TLR
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1 month
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Major Adverse Cardiac Events
Time Frame: 12 months
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cardiac death, target vessel MI, clinically indicated TLR
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12 months
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Major Adverse Cardiac Events
Time Frame: 24 months
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cardiac death, target vessel MI, clinically indicated TLR
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24 months
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Major Adverse Cardiac Events
Time Frame: 3 years
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cardiac death, target vessel MI, clinically indicated TLR
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3 years
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Major Adverse Cardiac Events
Time Frame: 4 years
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cardiac death, target vessel MI, clinically indicated TLR
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4 years
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Major Adverse Cardiac Events
Time Frame: 5 months
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cardiac death, target vessel MI, clinically indicated TLR
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5 months
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Clinically-Indicated Target Lesion Failure (TLF)
Time Frame: 1 month
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cardiac death, MI, clinically indicated TLR
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1 month
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Clinically-Indicated Target Lesion Failure (TLF)
Time Frame: 6 months
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cardiac death, MI, clinically indicated TLR
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6 months
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Clinically-Indicated Target Lesion Failure (TLF)
Time Frame: 1 year
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cardiac death, MI, clinically indicated TLR
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1 year
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Clinically-Indicated Target Lesion Failure (TLF)
Time Frame: 2 years
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cardiac death, MI, clinically indicated TLR
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2 years
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Clinically-Indicated Target Lesion Failure (TLF)
Time Frame: 3 years
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cardiac death, MI, clinically indicated TLR
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3 years
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Clinically-Indicated Target Lesion Failure (TLF)
Time Frame: 4 years
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cardiac death, MI, clinically indicated TLR
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4 years
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Clinically-Indicated Target Lesion Failure (TLF)
Time Frame: 5 years
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cardiac death, MI, clinically indicated TLR
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5 years
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Clinically-Indicated Target Vessel Failure (TVF)
Time Frame: 1 year
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cardiac death, MI, clinically indicated TVR
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1 year
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Clinically-Indicated Target Vessel Failure (TVF)
Time Frame: 2 years
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cardiac death, MI, clinically indicated TLR
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2 years
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Clinically-Indicated Target Vessel Failure (TVF)
Time Frame: 3 years
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cardiac death, MI, clinically indicated TLR
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3 years
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Clinically-Indicated Target Vessel Failure (TVF)
Time Frame: 4 years
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cardiac death, MI, clinically indicated TLR
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4 years
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Clinically-Indicated Target Vessel Failure (TVF)
Time Frame: 5 years
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cardiac death, MI, clinically indicated TLR
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5 years
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Scaffold Thrombosis
Time Frame: through 5 years
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ARC defined
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through 5 years
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute success - Procedure success
Time Frame: 7 days
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Acute Success is classified according to the following definitions: Procedure success - Successful delivery and deployment of the Clinical Investigation scaffold at the target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of < 50% by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure. |
7 days
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Acute success - Device success
Time Frame: 7 days
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Acute Success is classified according to the following definitions: Device success - Successful delivery and deployment of the Clinical Investigation scaffold at the target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis < 50% by QCA (by visual estimation if QCA is unavailable). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout subjects will be included as device success only if the above criteria for clinical device success are met. |
7 days
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alex Abizaid, MD, PhD, Instituto Dante Pazzanese de Cardiologia
- Principal Investigator: Stefan Verheye, MD, PhD, AZ Middelheim Hospital
- Principal Investigator: Joachim Schofer, MD, PhD, Universitäres Herz- und Gefäßzentrum
- Principal Investigator: John Ormiston, MD, Auckland City Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ELX-CL-1003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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