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Coronary Artery DiseasePhase 2NCT05033964

The DESyne BDS Plus RCT: A Randomized Clinical Trial to Assess the Elixir DESyne BDS Plus Drug Eluting Coronary Stent System for the Treatment of de Novo Native Coronary Artery Lesions

A Phase 2 study testing Percutaneous Coronary Intervention with drug eluting stents in people with Coronary Artery Disease, run by Elixir Medical Corporation at 14 sites in 5 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The objective of this clinical trial is to confirm the safety, effectiveness and performance of the DESyne BDS Plus Drug Eluting Coronary Stent System (DESyne BDS Plus DECSS) (Test) as compared to the CE Mark approved DESyne X2 Novolimus Eluting Coronary Stent System (DESyne X2 NECSS; DESyne X2) (Control) in the… 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?
Percutaneous Coronary Intervention with drug eluting stents
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
14 sitesin 5 countries
Study dates
15 Dec 2021to Mar 2026
Phase
Phase 2
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
  • Patient is able to understand the risks, benefits and treatment alternatives of receiving the DESyne BDS Plus DECSS or the DESyne X2 NECSS and provide written informed consent or oral consent (in urgent PCI) as allowed per hospital standard and as approved by the local Ethics Committee, prior to any clinical study-related procedure
  • Indication for a percutaneous intervention with stent implantation in native epicardial arteries including patients with stable coronary artery disease and acute coronary syndromes including NSTEMI and STEMI.
  • Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery
  • Patient agrees to undergo all clinical study required follow up visits, angiograms, and imaging testing (as applicable)
  • Patient agrees not to participate in any other clinical research study for a period of one year following the index procedure (long term follow-up or observational studies are permitted)
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  • Angiographic Inclusion Criteria
  • Target lesion(s) must be de novo coronary artery lesion(s) and must be located in a separate* vessel from other target or non-target lesions.
  • Target lesion(s) must have a reference vessel diameter (RVD) of ≥ 2.25 and ≤ 3.5 mm by visual estimation
  • Target lesion(s) must measure ≤ 34 mm in length, and able to be covered by a single device with 2 mm of healthy vessel on either side of planned implantation site
  • Target lesion(s) must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and <100%. When two target lesions are treated, they must be located in separate major epicardial vessels
  • Additional Inclusion Criteria for PK study:
  • Patients participating in PK study must meet all general and angiographic inclusion/exclusion criteria and may be treated with only the DESyne BDS Plus during Index Procedure.

Who cannot join

  • Acute myocardial infarction with Killip Class III and IV
  • Acute myocardial infarction requiring resuscitation
  • Acute myocardial infarction requiring IABP or ventilation support
  • Patient had fibrinolysis prior to PCI
  • Patient has current unstable ventricular arrhythmias
  • Patient has a known left ventricular ejection fraction (LVEF) < 30%
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  • Patient has received a heart transplant or any other organ transplant or is on a waiting list for an 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, other than steroids or has known immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.)
  • Patient has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, clopidogrel, prasugrel or ticagrelor, Novolimus, Sirolimus, Rivaroxaban, Argatroban, CoCr alloys, 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 or other P2Y12 inhibitors
  • Patient has severe renal dysfunction (CKD IV or V, eGFR <30) or is on dialysis
  • 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
  • Women of childbearing potential (unless they have a negative pregnancy test within 7 days of index procedure), or women who are pregnant or nursing
  • Patient has other medical conditions 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 be associated with a limited life expectancy (i.e., less than one year)
  • Patient is already participating in another clinical study which has not reached the primary endpoint (long-term follow-up or observational studies are permitted)
  • Angiographic Exclusion Criteria
  • Patient with vessel rupture and/or visible pericardial effusion
  • Target lesion aorto-ostial location or within 5mm of the origin of the vessel (LAD, LCX, RCA)
  • Target lesion is severely calcified and/or requires use of rotational atherectomy or cutting balloon, the use of shockwave or scoring balloon is allowed
  • Target Lesion located in the Left Main artery
  • Target Lesion located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft
  • Target Lesion involves a bifurcation >2.5 mm, or which requires a planned 2 or more stent technique
  • Previous placement of a stent within 10 mm of a target lesion
  • Another clinically-significant lesion (> 50%) is located in the same major epicardial vessel as a target lesion
  • Target vessel was previously treated with any type of PCI < 6 months prior to index procedure
  • Unsuccessful or complicated PCI in a non-target vessel < 48 hours prior to index procedure
  • Target vessel has a planned staged PCI ≤ 6 months after the index procedure
  • Additional Exclusion Criteria for PK study:
  • Target vessel was previously treated with any type of PCI < 6 months prior to index procedure
  • Patient with planned staged PCI within 90 days after study procedure
  • Patients who have a non-target lesion treated during the study procedure

Trial locations and contacts

14 sites in 5 countries.

14 sites in 5 countries

New Zealand6 sites

  • North Shore Hospital

    Auckland, 0622

  • Auckland City Hospital

    Auckland, 1023

  • Middlemore Hospital

    Auckland, 2025

  • Christchurch Hospital

    Christchurch, 8011

  • Dunedin Hospital

    Dunedin, 9016

  • Waikato Hospital

    Hamilton, 3240

Other trials in New Zealand

Belgium4 sites

  • ZNA Middelheim

    Antwerp, 2020

  • AZ Sint Jan Brugge Oostende AV

    Bruges, 8000

  • Ziekenhuis Oost-Limburg, Campus Sint Jan

    Genk, 3600

  • Universitaire Ziekenhuizen Leuven

    Leuven, 3000

Other trials in Belgium

Brazil2 sites

  • Instituto Dante Pazzanese

    São Paulo, 04012-909

  • Instituto do Coração da Faculdade

    São Paulo, 05403

Other trials in Brazil

Czechia1 site

  • General University Hospital

    Prague, 12808

Other trials in Czechia

Netherlands1 site

  • Catharina Hospital

    Eindhoven, 5623 EJ

Other trials in Netherlands

About this study

The objective of this clinical trial is to confirm the safety, effectiveness and performance of the DESyne BDS Plus Drug Eluting Coronary Stent System (DESyne BDS Plus DECSS) (Test) as compared to the CE Mark approved DESyne X2 Novolimus Eluting Coronary Stent System (DESyne X2 NECSS; DESyne X2) (Control) in the treatment of de novo native coronary artery lesions.

Read the detailed description

The DESyne BDS Plus Randomized Clinical Trial is a prospective, multi-center, single blind, randomized clinical study. Randomization (1:1; DESyne BDS Plus : DESyne X2) of up to 200 patients (100 in each arm) requiring treatment of up to two de novo coronary artery lesions ≤ 34 mm in length in vessels ≥ 2.25 mm and ≤ 3.5 mm in diameter will be conducted. The study will be conducted in two parts, with randomization of the first 100 subjects (Cohort 1) followed by the randomization of an additional 100 subjects (Cohort 2).

In an imaging subset of approximately 60 subjects (30 per arm), Angiography and OCT will be performed at index procedure, and again at 6-month follow-up.

The PK sub-study will enroll up to 10 non-randomized subjects treated only with the DESyne BDS Plus device, with a maximum of three DESyne BDS Plus stents implanted. The PK sub-study is being conducted to assess the blood pharmacokinetics of the three drugs (Sirolimus, Rivaroxaban, Argatroban) eluted from the DESyne BDS Plus after implantation. PK measurements will be conducted at 10 minutes, 30 minutes, 1, 2, 4, 6, 12, 24, 72 hours, and 7 days. In addition, all PK subjects will undergo clinical assessments/follow-up at 3 days or hospital discharge (whichever comes first), 1 month, 6 months, 12 months, 2 years, and 3 years.

Being tested
Percutaneous Coronary Intervention with drug eluting stents
Keywords
Drug Eluting Coronary Stent
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.

  • Percutaneous Coronary Intervention with drug eluting stentsCombination product

    Coronary drug eluting stent implantation

Study groups in NCT05033964
Study groupRoleWhat they receive
DESyne BDS Plus ArmExperimentalDESyne BDS Plus Drug Eluting Coronary Stent System (DESyne BDS Plus DECSS; DESyne BDS Plus) is loaded with Sirolimus, Rivaroxaban and Argatroban
Receives: Combination Product: Percutaneous Coronary Intervention with drug eluting stents
DESyne X2 ArmActive comparatorThe DESyne X2 Novolimus Eluting Coronary Stent System (DESyne X2 NECSS; DESyne X2) is loaded with Novolimus
Receives: Combination Product: Percutaneous Coronary Intervention with drug eluting stents

What is being measured

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

  1. Target lesion failure

    defined as a per-subject composite endpoint of cardiovascular death, target vessel MI, and clinically-indicated target lesion revascularization

    Measured: 3 days or through hospital discharge, whichever comes first

Secondary outcomes (33)

  1. Acute success

    defined as the successful delivery of the designated device and a final residual stenosis < 30% by QCA without TLF

    Measured: during hospital stay with a maximum of first seven days post index procedure

  2. Target lesion failure

    defined as a per-subject composite endpoint of cardiovascular death, target vessel MI, and clinically-indicated target lesion revascularization

    Measured: 30 days

  3. Target lesion failure

    defined as a per-subject composite endpoint of cardiovascular death, target vessel MI, and clinically-indicated target lesion revascularization

    Measured: 6 months

  4. Target lesion failure

    defined as a per-subject composite endpoint of cardiovascular death, target vessel MI, and clinically-indicated target lesion revascularization

    Measured: 12 months

  5. Target lesion failure

    defined as a per-subject composite endpoint of cardiovascular death, target vessel MI, and clinically-indicated target lesion revascularization

    Measured: 2 years

  6. Target lesion failure

    defined as a per-subject composite endpoint of cardiovascular death, target vessel MI, and clinically-indicated target lesion revascularization

    Measured: 3 years

  7. Death

    Cardiovascular and Non-cardiovascular

    Measured: 3 days or through hospital discharge, whichever comes first

  8. Death

    Cardiovascular and Non-cardiovascular

    Measured: 30 days

  9. Death

    Cardiovascular and Non-cardiovascular

    Measured: 6 months

  10. Death

    Cardiovascular and Non-cardiovascular

    Measured: 12 months

  11. Death

    Cardiovascular and Non-cardiovascular

    Measured: 2 years

  12. Death

    Cardiovascular and Non-cardiovascular

    Measured: 3 years

  13. Myocardial Infarction

    Q-wave and non-Q-wave; Target vessel and non-target vessel

    Measured: 3 days or through hospital discharge, whichever comes first

  14. Myocardial Infarction

    Q-wave and non-Q-wave; Target vessel and non-target vessel

    Measured: 30 days

  15. Myocardial Infarction

    Q-wave and non-Q-wave; Target vessel and non-target vessel

    Measured: 6 months

  16. Myocardial Infarction

    Q-wave and non-Q-wave; Target vessel and non-target vessel

    Measured: 12 months

  17. Myocardial Infarction

    Q-wave and non-Q-wave; Target vessel and non-target vessel

    Measured: 2 years

  18. Myocardial Infarction

    Q-wave and non-Q-wave; Target vessel and non-target vessel

    Measured: 3 years

  19. Target Lesion Revascularization

    Clinically indicated and non-clinically indicated

    Measured: 3 days or through hospital discharge, whichever comes first

  20. Target Lesion Revascularization

    Clinically indicated and non-clinically indicated

    Measured: 30 days

  21. Target Lesion Revascularization

    Clinically indicated and non-clinically indicated

    Measured: 6 months

  22. Target Lesion Revascularization

    Clinically indicated and non-clinically indicated

    Measured: 12 months

  23. Target Lesion Revascularization

    Clinically indicated and non-clinically indicated

    Measured: 2 Years

  24. Target Lesion Revascularization

    Clinically indicated and non-clinically indicated

    Measured: 3 Years

  25. Target Vessel Failure

    per-subject composite endpoint of cardiovascular death, target vessel MI, and clinically-indicated target vessel revascularization

    Measured: 3 days or through hospital discharge, whichever comes first

  26. Target Vessel Failure

    per-subject composite endpoint of cardiovascular death, target vessel MI, and clinically-indicated target vessel revascularization

    Measured: 30 days

  27. Target Vessel Failure

    per-subject composite endpoint of cardiovascular death, target vessel MI, and clinically-indicated target vessel revascularization

    Measured: 6 months

  28. Target Vessel Failure

    per-subject composite endpoint of cardiovascular death, target vessel MI, and clinically-indicated target vessel revascularization

    Measured: 12 months

  29. Target Vessel Failure

    per-subject composite endpoint of cardiovascular death, target vessel MI, and clinically-indicated target vessel revascularization

    Measured: 2 years

  30. Target Vessel Failure

    per-subject composite endpoint of cardiovascular death, target vessel MI, and clinically-indicated target vessel revascularization

    Measured: 3 years

  31. Late Lumen Loss

    powered secondary endpoint assessed by QCA in a subset of patients

    Measured: 6 months

  32. Optical Coherence Tomography (OCT) imaging

    assessment of the lesion and stent in a subset of patients.

    Measured: Post procedure and 6 months

  33. Pharmacokinetic profile of the drugs on the DESyne BDS Plus Stent

    assessment of the blood pharmacokinetics of the three drugs eluted from the DESyne BDS Plus after implantation

    Measured: pre-treatment, and post-treatment at 10 minutes, 30 minutes, 1, 2, 4, 6, 12, 24, 72 hours, and 7 days

Timeline

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

  1. First posted5 Sep 2021
  2. Study start15 Dec 2021
  3. Primary completion2 Dec 2022
  4. Study completionMar 2026 (estimated)

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
prospective, multi-center, single blind, randomized clinical study. Randomization is 1:1
Masking
Single blind
Who is masked
Participant
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05033964
Sponsor's protocol ID
ELX-CL-2005
Status last verified
Aug 2024
First submitted
17 Aug 2021
Last updated
27 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Percutaneous Coronary Intervention with drug eluting stents in people with Coronary Artery Disease, run by Elixir Medical Corporation at 14 sites in 5 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 13 inclusion and 33 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: status not confirmed, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in New Zealand, Belgium, Brazil, Czechia, Netherlands. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

Target lesion failure (time frame: 3 days or through hospital discharge, whichever comes first). 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 NCT05033964.

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 27 Aug 2024.

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