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Elixir Medical Clinical Evaluation of the DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System - The DESolve Nx Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02086045
Recruitment Status : Completed
First Posted : March 13, 2014
Last Update Posted : April 8, 2020
Sponsor:
Information provided by (Responsible Party):
Elixir Medical Corporation

Brief Summary:
To evaluate the safety, performance and efficacy of the Elixir DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System (BCSS) in patients with a single de novo native coronary artery lesion designated the target lesion and up to one non-target lesion located in a separate epicardial vessel.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 Start Date : November 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : May 15, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
DESolve Novolimus Eluting Bioresorbable Coronary Scaffold
DESolve Scaffold
Device: DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System
percutaneous coronary




Primary Outcome Measures :
  1. Clinically-indicated major adverse cardiac events (MACE) [ Time Frame: 6 months ]
    cardiac death, target vessel MI, clinically indicated TLR

  2. Late Lumen Loss [ Time Frame: 6 month ]
    MLD post procedure - MLD at follow-up


Secondary Outcome Measures :
  1. Major Adverse Cardiac Events [ Time Frame: 1 month ]
    cardiac death, target vessel MI, clinically indicated TLR

  2. Major Adverse Cardiac Events [ Time Frame: 12 months ]
    cardiac death, target vessel MI, clinically indicated TLR

  3. Major Adverse Cardiac Events [ Time Frame: 24 months ]
    cardiac death, target vessel MI, clinically indicated TLR

  4. Major Adverse Cardiac Events [ Time Frame: 3 years ]
    cardiac death, target vessel MI, clinically indicated TLR

  5. Major Adverse Cardiac Events [ Time Frame: 4 years ]
    cardiac death, target vessel MI, clinically indicated TLR

  6. Major Adverse Cardiac Events [ Time Frame: 5 months ]
    cardiac death, target vessel MI, clinically indicated TLR

  7. Clinically-Indicated Target Lesion Failure (TLF) [ Time Frame: 1 month ]
    cardiac death, MI, clinically indicated TLR

  8. Clinically-Indicated Target Lesion Failure (TLF) [ Time Frame: 6 months ]
    cardiac death, MI, clinically indicated TLR

  9. Clinically-Indicated Target Lesion Failure (TLF) [ Time Frame: 1 year ]
    cardiac death, MI, clinically indicated TLR

  10. Clinically-Indicated Target Lesion Failure (TLF) [ Time Frame: 2 years ]
    cardiac death, MI, clinically indicated TLR

  11. Clinically-Indicated Target Lesion Failure (TLF) [ Time Frame: 3 years ]
    cardiac death, MI, clinically indicated TLR

  12. Clinically-Indicated Target Lesion Failure (TLF) [ Time Frame: 4 years ]
    cardiac death, MI, clinically indicated TLR

  13. Clinically-Indicated Target Lesion Failure (TLF) [ Time Frame: 5 years ]
    cardiac death, MI, clinically indicated TLR

  14. Clinically-Indicated Target Vessel Failure (TVF) [ Time Frame: 1 year ]
    cardiac death, MI, clinically indicated TVR

  15. Clinically-Indicated Target Vessel Failure (TVF) [ Time Frame: 2 years ]
    cardiac death, MI, clinically indicated TLR

  16. Clinically-Indicated Target Vessel Failure (TVF) [ Time Frame: 3 years ]
    cardiac death, MI, clinically indicated TLR

  17. Clinically-Indicated Target Vessel Failure (TVF) [ Time Frame: 4 years ]
    cardiac death, MI, clinically indicated TLR

  18. Clinically-Indicated Target Vessel Failure (TVF) [ Time Frame: 5 years ]
    cardiac death, MI, clinically indicated TLR

  19. Scaffold Thrombosis [ Time Frame: through 5 years ]
    ARC defined


Other Outcome Measures:
  1. Acute success - Procedure success [ Time Frame: 7 days ]

    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.


  2. Acute success - Device success [ Time Frame: 7 days ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

    1. Not part of a clinical investigation
    2. ≥ 6 months prior to the study index procedure
    3. ≥ 9 months after the study index procedure (planned)
    4. 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:

    1. Aorto-ostial location
    2. Left main location
    3. Located within 5 mm of the origin of the LAD or LCX
    4. Located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft
    5. Lesion involving a side branch >2mm in diameter or bifurcation
    6. Previous placement of a scaffold proximal to or within 10 mm of the target lesion
    7. Total occlusion (TIMI flow 0), or TIMI flow < 1
    8. Excessive tortuosity proximal to or within the lesion
    9. Angulation (≥ 45o) proximal to or within the lesion
    10. Calcification moderate or heavy
    11. 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02086045


Locations
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Belgium
AZ Middelheim Hospital
Antwerp, Belgium, 2020
St. - Jan Ziekenhuis Z.O.L.
Genk, Belgium, B-3600
Brazil
Instituto Dante Pazzanese
Sao Paulo, Brazil, 0401210
ICT / Instituto Do Coracao Do Triangulo Mineiro
Uberlandia, Brazil, 38400-368
Denmark
Aarhus University Hospital, Skejby
Aarhus N, Denmark, 8200
Germany
Charite - Campus Benjamin Franklin
Berlin, Germany, 12203
Universitäres Herz- und Gefäßzentrum
Hamburg, Germany, 22527
New Zealand
North Shore Hospital
Auckland, New Zealand, 0622
Auckland City Hospital
Auckland, New Zealand, 1023
Mercy Angiography Unit
Auckland, New Zealand, 1023
Poland
Polsko-Amerykańskie Kliniki Serca
Dąbrowa Górnicza, Poland, 43-300
Centrum Interwencyjnego Leczenia Chorób Serca
Krakow, Poland, 31-202
Jagiellonian University
Krakow, Poland, 31-501
Sponsors and Collaborators
Elixir Medical Corporation
Investigators
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Principal Investigator: Alex Abizaid, MD, PhD Instituto Dante Pazzanese de Cardiologia
Principal Investigator: Stefan Verheye, MD, PhD AZ Middelheim Hospital
Principal Investigator: John Ormiston, MD Auckland City Hospital
Principal Investigator: Joachim Schofer, MD, PhD Universitäres Herz- und Gefäßzentrum
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Elixir Medical Corporation
ClinicalTrials.gov Identifier: NCT02086045    
Other Study ID Numbers: ELX-CL-1003
First Posted: March 13, 2014    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: April 2020
Keywords provided by Elixir Medical Corporation:
Coronary artery disease
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases