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Coronary Artery DiseaseNCT04034121

Elixir Medical Evaluation of the DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System - Cx Registry

A study testing DESolve Cx drug eluting coronary scaffold system in people with Coronary Artery Disease, run by Elixir Medical Corporation at 3 sites in 2 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

This additional arm of the DESolve Nx study is an evaluation of the CE Mark approved DESolve Cx Novolimus Eluting Bioresorbable Scaffold System. 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 Cx drug eluting coronary scaffold system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
3 sitesin 2 countries
Study dates
20 Jan 2016to 30 Sep 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 Novolimus Eluting Bioresorbable Coronary Scaffold System (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, imaging testing
  • Patient must agree not to participate in any other clinical study for a period of two years following the index procedure
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  • Target lesion must be located in a native coronary artery with a nominal vessel
  • Not part of a clinical investigation
  • Treatment of a single, non-target lesion located in a separate major epicardial vessel Target vessel diameter must be a diameter of between 2.25 and 3.5 mm assessed by online QCA
  • Target lesion must measure ≤ 24 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
  • Target vessel must be in a major coronary artery or major branch

Who cannot join

  • Patient has a known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure and cardiac enzymes 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 36Show 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
  • 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

3 sites in 2 countries.

3 sites in 2 countries

Belgium2 sites

  • AZ Middelheim Hospital

    Antwerp, 2020

  • St. - Jan Ziekenhuis Z.O.L.

    Genk, B-3600

Other trials in Belgium

Brazil1 site

  • Instituto Dante Pazzanese

    São Paulo, 0401210

Other trials in Brazil

About this study

Official title: Non-randomized Evaluation of the DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System in de Novo Native Coronary Artery Lesions - DESolve Cx Single-Arm Registry

This additional arm of the DESolve Nx study is an evaluation of the CE Mark approved DESolve Cx Novolimus Eluting Bioresorbable Scaffold System.

Read the detailed description

The DESolve Cx Single-Arm Registry enrolled patients using the same inclusion and exclusion criteria and clinical endpoints as the DESolve Nx Study

This study was split into 2 cohorts - European and Brazilian. The European cohort (30 subjects) completed all follow-up at 1 year and the Brazilian cohort at 3 years (20 subjects)

Being tested
DESolve Cx drug eluting coronary scaffold system
Keywords
biorersorbable scaffold, drug eluting, novolimus
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 Cx drug eluting coronary scaffold systemDevice

    percutaneous coronary intervention

Study groups in NCT04034121
Study groupRoleWhat they receive
DESolve CxOtherDESolve Cx Novolimus Eluting Bioresorbable Coronary Scaffold System
Receives: Device: DESolve Cx drug eluting 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

    Number of Participants with one or more Clinically-indicated Major Adverse Cardiac Events This applies to the European and Brazilian Cohorts

    Measured: 6 months

Secondary outcomes (4)

  1. In-scaffold Late Lumen Loss by Quantitative Coronary Angiography (QCA)

    quantitative QCA measurement of change in the lumen diameter from post procedure and 6 months which is described as "late lumen loss" This applies to both the European and Brazilian Cohorts

    Measured: 6 months

  2. Clinically-indicated Major Adverse Cardiac Events (MACE)

    Number of Participants with one or more Clinically-indicated Major Adverse Cardiac Events This applies to both the European and Brazilian Cohorts

    Measured: 12 months

  3. Clinically-Indicated Major Adverse Cardiac Events

    Number of Participants with one or more Clinically-indicated Major Adverse Cardiac Events This time point applies to the Brazilian Cohort only

    Measured: 24 months

  4. Clinically-indicated Major Adverse Cardiac Events

    Number of Participants with one or more Clinically-indicated Major Adverse Cardiac Events This applies to the Brazilian Cohort only

    Measured: 36 months

Timeline

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

  1. First posted26 Jul 2019
  2. Study start20 Jan 2016
  3. Primary completion22 Jan 2017
  4. Study completion30 Sep 2020

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
Model description
single arm
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04034121
Sponsor's protocol ID
ELX-CL-1003 Cx
Status last verified
Jul 2021
First submitted
6 Feb 2019
Last updated
14 Jul 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing DESolve Cx drug eluting coronary scaffold system in people with Coronary Artery Disease, run by Elixir Medical Corporation at 3 sites in 2 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 12 inclusion and 36 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 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Belgium, Brazil. 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?

Yes. Results are posted in the registry (first posted 14 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 (time frame: 6 months). 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 NCT04034121.

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 14 Jul 2021.

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