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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05033964




Registration number
NCT05033964
Ethics application status
Date submitted
17/08/2021
Date registered
5/09/2021
Date last updated
18/04/2023

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 0 0
ELX-CL-2005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Combination Product - Percutaneous Coronary Intervention with drug eluting stents

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

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
Coronary drug eluting stent implantation
Intervention code [1] 0 0
Combination Product
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Target lesion failure
Timepoint [1] 0 0
3 days or through hospital discharge, whichever comes first
Secondary outcome [1] 0 0
Acute success
Timepoint [1] 0 0
during hospital stay with a maximum of first seven days post index procedure
Secondary outcome [2] 0 0
Target lesion failure
Timepoint [2] 0 0
30 days
Secondary outcome [3] 0 0
Target lesion failure
Timepoint [3] 0 0
6 months
Secondary outcome [4] 0 0
Target lesion failure
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
Target lesion failure
Timepoint [5] 0 0
2 years
Secondary outcome [6] 0 0
Target lesion failure
Timepoint [6] 0 0
3 years
Secondary outcome [7] 0 0
Death
Timepoint [7] 0 0
3 days or through hospital discharge, whichever comes first
Secondary outcome [8] 0 0
Death
Timepoint [8] 0 0
30 days
Secondary outcome [9] 0 0
Death
Timepoint [9] 0 0
6 months
Secondary outcome [10] 0 0
Death
Timepoint [10] 0 0
12 months
Secondary outcome [11] 0 0
Death
Timepoint [11] 0 0
2 years
Secondary outcome [12] 0 0
Death
Timepoint [12] 0 0
3 years
Secondary outcome [13] 0 0
Myocardial Infarction
Timepoint [13] 0 0
3 days or through hospital discharge, whichever comes first
Secondary outcome [14] 0 0
Myocardial Infarction
Timepoint [14] 0 0
30 days
Secondary outcome [15] 0 0
Myocardial Infarction
Timepoint [15] 0 0
6 months
Secondary outcome [16] 0 0
Myocardial Infarction
Timepoint [16] 0 0
12 months
Secondary outcome [17] 0 0
Myocardial Infarction
Timepoint [17] 0 0
2 years
Secondary outcome [18] 0 0
Myocardial Infarction
Timepoint [18] 0 0
3 years
Secondary outcome [19] 0 0
Target Lesion Revascularization
Timepoint [19] 0 0
3 days or through hospital discharge, whichever comes first
Secondary outcome [20] 0 0
Target Lesion Revascularization
Timepoint [20] 0 0
30 days
Secondary outcome [21] 0 0
Target Lesion Revascularization
Timepoint [21] 0 0
6 months
Secondary outcome [22] 0 0
Target Lesion Revascularization
Timepoint [22] 0 0
12 months
Secondary outcome [23] 0 0
Target Lesion Revascularization
Timepoint [23] 0 0
2 Years
Secondary outcome [24] 0 0
Target Lesion Revascularization
Timepoint [24] 0 0
3 Years
Secondary outcome [25] 0 0
Target Vessel Failure
Timepoint [25] 0 0
3 days or through hospital discharge, whichever comes first
Secondary outcome [26] 0 0
Target Vessel Failure
Timepoint [26] 0 0
30 days
Secondary outcome [27] 0 0
Target Vessel Failure
Timepoint [27] 0 0
6 months
Secondary outcome [28] 0 0
Target Vessel Failure
Timepoint [28] 0 0
12 months
Secondary outcome [29] 0 0
Target Vessel Failure
Timepoint [29] 0 0
2 years
Secondary outcome [30] 0 0
Target Vessel Failure
Timepoint [30] 0 0
3 years
Secondary outcome [31] 0 0
Late Lumen Loss
Timepoint [31] 0 0
6 months
Secondary outcome [32] 0 0
Optical Coherence Tomography (OCT) imaging
Timepoint [32] 0 0
Post procedure and 6 months
Secondary outcome [33] 0 0
Pharmacokinetic profile of the drugs on the DESyne BDS Plus Stent
Timepoint [33] 0 0
pre-treatment, and post-treatment at 10 minutes, 30 minutes, 1, 2, 4, 6, 12, 24, 72 hours, and 7 days

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2026
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Antwerp
Country [2] 0 0
Belgium
State/province [2] 0 0
Brugge
Country [3] 0 0
Belgium
State/province [3] 0 0
Genk
Country [4] 0 0
Belgium
State/province [4] 0 0
Leuven
Country [5] 0 0
Brazil
State/province [5] 0 0
São Paulo
Country [6] 0 0
Czechia
State/province [6] 0 0
Prague
Country [7] 0 0
Netherlands
State/province [7] 0 0
Eindhoven
Country [8] 0 0
New Zealand
State/province [8] 0 0
Auckland
Country [9] 0 0
New Zealand
State/province [9] 0 0
Christchurch
Country [10] 0 0
New Zealand
State/province [10] 0 0
Dunedin
Country [11] 0 0
New Zealand
State/province [11] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Elixir Medical Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05033964
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stefan Verheye, MD, PHD
Address 0 0
Ziekenhuis Netwerk Antwerpen (ZNA) Middelheim, Antwerp, Belgium
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries