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Active, not recruitingNCT05033964Updated Aug 27, 2024

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 interventional study of Percutaneous Coronary Intervention with drug eluting stents in Coronary Artery Disease, sponsored by Elixir Medical Corporation. Active, not recruiting at 14 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-27.

Sponsored by Elixir Medical Corporation · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • Drug Eluting Coronary Stent
03

In context

Coronary Artery Disease

5,596 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.

This study's planned enrollment of 200 is above the median of 123 across 3,435 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Elixir Medical Corporation is the lead sponsor of 18 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patient must be at least 18 years of age
  2. 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
  3. 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.
  4. Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery
  5. Patient agrees to undergo all clinical study required follow up visits, angiograms, and imaging testing (as applicable)

  6. 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)

    Angiographic Inclusion Criteria

  7. 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.
  8. Target lesion(s) must have a reference vessel diameter (RVD) of ≥ 2.25 and ≤ 3.5 mm by visual estimation
  9. 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

  10. 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:

  11. 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.

Exclusion criteria

Exclusion Criteria:

  1. Acute myocardial infarction with Killip Class III and IV
  2. Acute myocardial infarction requiring resuscitation
  3. Acute myocardial infarction requiring IABP or ventilation support
  4. Patient had fibrinolysis prior to PCI
  5. Patient has current unstable ventricular arrhythmias
  6. Patient has a known left ventricular ejection fraction (LVEF) \< 30%
  7. Patient has received a heart transplant or any other organ transplant or is on a waiting list for an organ transplant
  8. Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure
  9. Patient is receiving immunosuppression therapy, other than steroids or has known immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.)
  10. 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
  11. Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin or clopidogrel or other P2Y12 inhibitors
  12. Patient has severe renal dysfunction (CKD IV or V, eGFR \<30) or is on dialysis
  13. Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months
  14. Patient has had a significant GI or urinary bleed within the past six months
  15. Women of childbearing potential (unless they have a negative pregnancy test within 7 days of index procedure), or women who are pregnant or nursing
  16. 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)

  17. 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

  18. Patient with vessel rupture and/or visible pericardial effusion
  19. Target lesion aorto-ostial location or within 5mm of the origin of the vessel (LAD, LCX, RCA)
  20. Target lesion is severely calcified and/or requires use of rotational atherectomy or cutting balloon, the use of shockwave or scoring balloon is allowed
  21. Target Lesion located in the Left Main artery
  22. Target Lesion located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft
  23. Target Lesion involves a bifurcation >2.5 mm, or which requires a planned 2 or more stent technique
  24. Previous placement of a stent within 10 mm of a target lesion
  25. Another clinically-significant lesion (> 50%) is located in the same major epicardial vessel as a target lesion
  26. Target vessel was previously treated with any type of PCI \< 6 months prior to index procedure
  27. Unsuccessful or complicated PCI in a non-target vessel \< 48 hours prior to index procedure

  28. Target vessel has a planned staged PCI ≤ 6 months after the index procedure

    Additional Exclusion Criteria for PK study:

  29. Target vessel was previously treated with any type of PCI \< 6 months prior to index procedure
  30. Patient with planned staged PCI within 90 days after study procedure
  31. Patients who have a non-target lesion treated during the study procedure
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    DESyne BDS Plus Arm

    DESyne BDS Plus Drug Eluting Coronary Stent System (DESyne BDS Plus DECSS; DESyne BDS Plus) is loaded with Sirolimus, Rivaroxaban and Argatroban

    Combination Product: Percutaneous Coronary Intervention with drug eluting stents

  • Active comparator
    DESyne X2 Arm

    The DESyne X2 Novolimus Eluting Coronary Stent System (DESyne X2 NECSS; DESyne X2) is loaded with Novolimus

    Combination Product: Percutaneous Coronary Intervention with drug eluting stents

Interventions

  • Combination productPercutaneous Coronary Intervention with drug eluting stents

    Coronary drug eluting stent implantation

06

What researchers measure

Primary outcomes

  1. Target lesion failure

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

    Time frame: 3 days or through hospital discharge, whichever comes first

Secondary outcomes

  1. Acute success

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 3 years

  7. Death

    Cardiovascular and Non-cardiovascular

    Time frame: 3 days or through hospital discharge, whichever comes first

  8. Death

    Cardiovascular and Non-cardiovascular

    Time frame: 30 days

  9. Death

    Cardiovascular and Non-cardiovascular

    Time frame: 6 months

  10. Death

    Cardiovascular and Non-cardiovascular

    Time frame: 12 months

  11. Death

    Cardiovascular and Non-cardiovascular

    Time frame: 2 years

  12. Death

    Cardiovascular and Non-cardiovascular

    Time frame: 3 years

  13. Myocardial Infarction

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

    Time frame: 3 days or through hospital discharge, whichever comes first

  14. Myocardial Infarction

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

    Time frame: 30 days

  15. Myocardial Infarction

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

    Time frame: 6 months

  16. Myocardial Infarction

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

    Time frame: 12 months

  17. Myocardial Infarction

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

    Time frame: 2 years

  18. Myocardial Infarction

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

    Time frame: 3 years

  19. Target Lesion Revascularization

    Clinically indicated and non-clinically indicated

    Time frame: 3 days or through hospital discharge, whichever comes first

  20. Target Lesion Revascularization

    Clinically indicated and non-clinically indicated

    Time frame: 30 days

  21. Target Lesion Revascularization

    Clinically indicated and non-clinically indicated

    Time frame: 6 months

  22. Target Lesion Revascularization

    Clinically indicated and non-clinically indicated

    Time frame: 12 months

  23. Target Lesion Revascularization

    Clinically indicated and non-clinically indicated

    Time frame: 2 Years

  24. Target Lesion Revascularization

    Clinically indicated and non-clinically indicated

    Time frame: 3 Years

  25. Target Vessel Failure

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

    Time frame: 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

    Time frame: 30 days

  27. Target Vessel Failure

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

    Time frame: 6 months

  28. Target Vessel Failure

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

    Time frame: 12 months

  29. Target Vessel Failure

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

    Time frame: 2 years

  30. Target Vessel Failure

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

    Time frame: 3 years

  31. Late Lumen Loss

    powered secondary endpoint assessed by QCA in a subset of patients

    Time frame: 6 months

  32. Optical Coherence Tomography (OCT) imaging

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

    Time frame: 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

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

07

Study locations

14 sites
  • ZNA Middelheim
    Antwerp, 2020, Belgium
  • AZ Sint Jan Brugge Oostende AV
    Brugge, 8000, Belgium
  • Ziekenhuis Oost-Limburg, Campus Sint Jan
    Genk, 3600, Belgium
  • Universitaire Ziekenhuizen Leuven
    Leuven, 3000, Belgium
  • Instituto Dante Pazzanese
    São Paulo, 04012-909, Brazil
  • Instituto do Coração da Faculdade
    São Paulo, 05403, Brazil
  • General University Hospital
    Prague, 12808, Czechia
  • Catharina Hospital
    Eindhoven, 5623 EJ, Netherlands
  • North Shore Hospital
    Auckland, 0622, New Zealand
  • Auckland City Hospital
    Auckland, 1023, New Zealand
  • Middlemore Hospital
    Auckland, 2025, New Zealand
  • Christchurch Hospital
    Christchurch, 8011, New Zealand
  • Dunedin Hospital
    Dunedin, 9016, New Zealand
  • Waikato Hospital
    Hamilton, 3240, New Zealand
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05033964
Lead sponsor
Elixir Medical Corporation
Responsible party
Sponsor
First posted
Sep 5, 2021
Start date
Dec 15, 2021
Primary completion
Dec 2, 2022
Completion
Mar 2026 (estimated)
Last update
Aug 27, 2024

Study contacts

Stefan Verheye, MD, PHD
principal investigator · Ziekenhuis Netwerk Antwerpen (ZNA) Middelheim, Antwerp, Belgium
Mark Webster, MBChB
principal investigator · Auckland City Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is active, not recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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