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Coronary Artery DiseaseNCT02086045

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

A study testing DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System in people with Coronary Artery Disease, run by Elixir Medical Corporation at 13 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
13 sitesin 6 countries
Study dates
Nov 2011to 15 May 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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

Who cannot join

  • 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
Show all 37Show fewer
  • 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)

Trial locations and contacts

13 sites in 6 countries.

13 sites in 6 countries

New Zealand3 sites

  • North Shore Hospital

    Auckland, 0622

  • Auckland City Hospital

    Auckland, 1023

  • Mercy Angiography Unit

    Auckland, 1023

Other trials in New Zealand

Poland3 sites

  • Polsko-Amerykańskie Kliniki Serca

    Dąbrowa Górnicza, 43-300

  • Centrum Interwencyjnego Leczenia Chorób Serca

    Krakow, 31-202

  • Jagiellonian University

    Krakow, 31-501

Other trials in Poland

Belgium2 sites

  • AZ Middelheim Hospital

    Antwerp, 2020

  • St. - Jan Ziekenhuis Z.O.L.

    Genk, B-3600

Other trials in Belgium

Brazil2 sites

  • Instituto Dante Pazzanese

    São Paulo, 0401210

  • ICT / Instituto Do Coracao Do Triangulo Mineiro

    Uberlândia, 38400-368

Other trials in Brazil

Germany2 sites

  • Charite - Campus Benjamin Franklin

    Berlin, 12203

  • Universitäres Herz- und Gefäßzentrum

    Hamburg, 22527

Other trials in Germany

Denmark1 site

  • Aarhus University Hospital, Skejby

    Aarhus N, 8200

Other trials in Denmark

About this study

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

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.

Being tested
DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System
Keywords
Coronary artery disease
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DESolve Novolimus Eluting Bioresorbable Coronary Scaffold SystemDevice

    percutaneous coronary

Study groups in NCT02086045
Study groupRoleWhat they receive
DESolve Novolimus Eluting Bioresorbable Coronary ScaffoldOtherDESolve Scaffold
Receives: Device: DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinically-indicated major adverse cardiac events (MACE)

    cardiac death, target vessel MI, clinically indicated TLR

    Measured: 6 months

  2. Late Lumen Loss

    MLD post procedure - MLD at follow-up

    Measured: 6 month

Secondary outcomes (19)

  1. Major Adverse Cardiac Events

    cardiac death, target vessel MI, clinically indicated TLR

    Measured: 1 month

  2. Major Adverse Cardiac Events

    cardiac death, target vessel MI, clinically indicated TLR

    Measured: 12 months

  3. Major Adverse Cardiac Events

    cardiac death, target vessel MI, clinically indicated TLR

    Measured: 24 months

  4. Major Adverse Cardiac Events

    cardiac death, target vessel MI, clinically indicated TLR

    Measured: 3 years

  5. Major Adverse Cardiac Events

    cardiac death, target vessel MI, clinically indicated TLR

    Measured: 4 years

  6. Major Adverse Cardiac Events

    cardiac death, target vessel MI, clinically indicated TLR

    Measured: 5 months

  7. Clinically-Indicated Target Lesion Failure (TLF)

    cardiac death, MI, clinically indicated TLR

    Measured: 1 month

  8. Clinically-Indicated Target Lesion Failure (TLF)

    cardiac death, MI, clinically indicated TLR

    Measured: 6 months

  9. Clinically-Indicated Target Lesion Failure (TLF)

    cardiac death, MI, clinically indicated TLR

    Measured: 1 year

  10. Clinically-Indicated Target Lesion Failure (TLF)

    cardiac death, MI, clinically indicated TLR

    Measured: 2 years

  11. Clinically-Indicated Target Lesion Failure (TLF)

    cardiac death, MI, clinically indicated TLR

    Measured: 3 years

  12. Clinically-Indicated Target Lesion Failure (TLF)

    cardiac death, MI, clinically indicated TLR

    Measured: 4 years

  13. Clinically-Indicated Target Lesion Failure (TLF)

    cardiac death, MI, clinically indicated TLR

    Measured: 5 years

  14. Clinically-Indicated Target Vessel Failure (TVF)

    cardiac death, MI, clinically indicated TVR

    Measured: 1 year

  15. Clinically-Indicated Target Vessel Failure (TVF)

    cardiac death, MI, clinically indicated TLR

    Measured: 2 years

  16. Clinically-Indicated Target Vessel Failure (TVF)

    cardiac death, MI, clinically indicated TLR

    Measured: 3 years

  17. Clinically-Indicated Target Vessel Failure (TVF)

    cardiac death, MI, clinically indicated TLR

    Measured: 4 years

  18. Clinically-Indicated Target Vessel Failure (TVF)

    cardiac death, MI, clinically indicated TLR

    Measured: 5 years

  19. Scaffold Thrombosis

    ARC defined

    Measured: through 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2014 (estimated)
  2. Study startNov 2011
  3. Primary completionJun 2013
  4. Study completion15 May 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02086045
Sponsor's protocol ID
ELX-CL-1003
Status last verified
Sep 2023
First submitted
10 Mar 2014
Last updated
7 Sep 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • Abizaid A, Costa RA, Schofer J, Ormiston J, Maeng M, Witzenbichler B, Botelho RV, Costa JR Jr, Chamie D, Abizaid AS, Castro JP, Morrison L, Toyloy S, Bhat V, Yan J, Verheye S. Serial Multimodality Imaging and 2-Year Clinical Outcomes of the Novel DESolve Novolimus-Eluting Bioresorbable Coronary Scaffold System for the Treatment of Single De Novo Coronary Lesions. JACC Cardiovasc Interv. 2016 Mar 28;9(6):565-74. doi: 10.1016/j.jcin.2015.12.004.

    PubMed 27013155

Questions about this trial

What is this clinical trial studying?

A study testing DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System in people with Coronary Artery Disease, run by Elixir Medical Corporation at 13 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in New Zealand, Poland, Belgium, Brazil, Germany and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinically-indicated major adverse cardiac events (MACE) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02086045, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.

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