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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

Primary Purpose

Coronary Artery Disease

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Percutaneous Coronary Intervention with drug eluting stents
Sponsored by
Elixir Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Drug Eluting Coronary Stent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 may be treated with only the DESyne BDS Plus during Index Procedure.

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 scoring 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

Sites / Locations

  • ZNA Middelheim
  • AZ Sint Jan Brugge Oostende AV
  • Ziekenhuis Oost-Limburg, Campus Sint Jan
  • Universitaire Ziekenhuizen Leuven
  • Instituto Dante Pazzanese
  • Instituto do Coração da Faculdade
  • General University Hospital
  • Catharina Hospital
  • North Shore Hospital
  • Auckland City Hospital
  • Middlemore Hospital
  • Christchurch Hospital
  • Dunedin Hospital
  • Waikato Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DESyne BDS Plus Arm

DESyne X2 Arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Acute success
defined as the successful delivery of the designated device and a final residual stenosis < 30% by QCA without TLF
Target lesion failure
defined as a per-subject composite endpoint of cardiovascular death, target vessel MI, and clinically-indicated target lesion revascularization
Target lesion failure
defined as a per-subject composite endpoint of cardiovascular death, target vessel MI, and clinically-indicated target lesion revascularization
Target lesion failure
defined as a per-subject composite endpoint of cardiovascular death, target vessel MI, and clinically-indicated target lesion revascularization
Target lesion failure
defined as a per-subject composite endpoint of cardiovascular death, target vessel MI, and clinically-indicated target lesion revascularization
Target lesion failure
defined as a per-subject composite endpoint of cardiovascular death, target vessel MI, and clinically-indicated target lesion revascularization
Death
Cardiovascular and Non-cardiovascular
Death
Cardiovascular and Non-cardiovascular
Death
Cardiovascular and Non-cardiovascular
Death
Cardiovascular and Non-cardiovascular
Death
Cardiovascular and Non-cardiovascular
Death
Cardiovascular and Non-cardiovascular
Myocardial Infarction
Q-wave and non-Q-wave; Target vessel and non-target vessel
Myocardial Infarction
Q-wave and non-Q-wave; Target vessel and non-target vessel
Myocardial Infarction
Q-wave and non-Q-wave; Target vessel and non-target vessel
Myocardial Infarction
Q-wave and non-Q-wave; Target vessel and non-target vessel
Myocardial Infarction
Q-wave and non-Q-wave; Target vessel and non-target vessel
Myocardial Infarction
Q-wave and non-Q-wave; Target vessel and non-target vessel
Target Lesion Revascularization
Clinically indicated and non-clinically indicated
Target Lesion Revascularization
Clinically indicated and non-clinically indicated
Target Lesion Revascularization
Clinically indicated and non-clinically indicated
Target Lesion Revascularization
Clinically indicated and non-clinically indicated
Target Lesion Revascularization
Clinically indicated and non-clinically indicated
Target Lesion Revascularization
Clinically indicated and non-clinically indicated
Target Vessel Failure
per-subject composite endpoint of cardiovascular death, target vessel MI, and clinically-indicated target vessel revascularization
Target Vessel Failure
per-subject composite endpoint of cardiovascular death, target vessel MI, and clinically-indicated target vessel revascularization
Target Vessel Failure
per-subject composite endpoint of cardiovascular death, target vessel MI, and clinically-indicated target vessel revascularization
Target Vessel Failure
per-subject composite endpoint of cardiovascular death, target vessel MI, and clinically-indicated target vessel revascularization
Target Vessel Failure
per-subject composite endpoint of cardiovascular death, target vessel MI, and clinically-indicated target vessel revascularization
Target Vessel Failure
per-subject composite endpoint of cardiovascular death, target vessel MI, and clinically-indicated target vessel revascularization
Late Lumen Loss
powered secondary endpoint assessed by QCA in a subset of patients
Optical Coherence Tomography (OCT) imaging
assessment of the lesion and stent in a subset of patients.
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

Full Information

First Posted
August 17, 2021
Last Updated
April 14, 2023
Sponsor
Elixir Medical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05033964
Brief 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
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
December 2, 2022 (Actual)
Study Completion Date
March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Elixir Medical Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Drug Eluting Coronary Stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
prospective, multi-center, single blind, randomized clinical study. Randomization is 1:1
Masking
Participant
Masking Description
single blind
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DESyne BDS Plus Arm
Arm Type
Experimental
Arm Description
DESyne BDS Plus Drug Eluting Coronary Stent System (DESyne BDS Plus DECSS; DESyne BDS Plus) is loaded with Sirolimus, Rivaroxaban and Argatroban
Arm Title
DESyne X2 Arm
Arm Type
Active Comparator
Arm Description
The DESyne X2 Novolimus Eluting Coronary Stent System (DESyne X2 NECSS; DESyne X2) is loaded with Novolimus
Intervention Type
Combination Product
Intervention Name(s)
Percutaneous Coronary Intervention with drug eluting stents
Intervention Description
Coronary drug eluting stent implantation
Primary Outcome Measure Information:
Title
Target lesion failure
Description
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 Outcome Measure Information:
Title
Acute success
Description
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
Title
Target lesion failure
Description
defined as a per-subject composite endpoint of cardiovascular death, target vessel MI, and clinically-indicated target lesion revascularization
Time Frame
30 days
Title
Target lesion failure
Description
defined as a per-subject composite endpoint of cardiovascular death, target vessel MI, and clinically-indicated target lesion revascularization
Time Frame
6 months
Title
Target lesion failure
Description
defined as a per-subject composite endpoint of cardiovascular death, target vessel MI, and clinically-indicated target lesion revascularization
Time Frame
12 months
Title
Target lesion failure
Description
defined as a per-subject composite endpoint of cardiovascular death, target vessel MI, and clinically-indicated target lesion revascularization
Time Frame
2 years
Title
Target lesion failure
Description
defined as a per-subject composite endpoint of cardiovascular death, target vessel MI, and clinically-indicated target lesion revascularization
Time Frame
3 years
Title
Death
Description
Cardiovascular and Non-cardiovascular
Time Frame
3 days or through hospital discharge, whichever comes first
Title
Death
Description
Cardiovascular and Non-cardiovascular
Time Frame
30 days
Title
Death
Description
Cardiovascular and Non-cardiovascular
Time Frame
6 months
Title
Death
Description
Cardiovascular and Non-cardiovascular
Time Frame
12 months
Title
Death
Description
Cardiovascular and Non-cardiovascular
Time Frame
2 years
Title
Death
Description
Cardiovascular and Non-cardiovascular
Time Frame
3 years
Title
Myocardial Infarction
Description
Q-wave and non-Q-wave; Target vessel and non-target vessel
Time Frame
3 days or through hospital discharge, whichever comes first
Title
Myocardial Infarction
Description
Q-wave and non-Q-wave; Target vessel and non-target vessel
Time Frame
30 days
Title
Myocardial Infarction
Description
Q-wave and non-Q-wave; Target vessel and non-target vessel
Time Frame
6 months
Title
Myocardial Infarction
Description
Q-wave and non-Q-wave; Target vessel and non-target vessel
Time Frame
12 months
Title
Myocardial Infarction
Description
Q-wave and non-Q-wave; Target vessel and non-target vessel
Time Frame
2 years
Title
Myocardial Infarction
Description
Q-wave and non-Q-wave; Target vessel and non-target vessel
Time Frame
3 years
Title
Target Lesion Revascularization
Description
Clinically indicated and non-clinically indicated
Time Frame
3 days or through hospital discharge, whichever comes first
Title
Target Lesion Revascularization
Description
Clinically indicated and non-clinically indicated
Time Frame
30 days
Title
Target Lesion Revascularization
Description
Clinically indicated and non-clinically indicated
Time Frame
6 months
Title
Target Lesion Revascularization
Description
Clinically indicated and non-clinically indicated
Time Frame
12 months
Title
Target Lesion Revascularization
Description
Clinically indicated and non-clinically indicated
Time Frame
2 Years
Title
Target Lesion Revascularization
Description
Clinically indicated and non-clinically indicated
Time Frame
3 Years
Title
Target Vessel Failure
Description
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
Title
Target Vessel Failure
Description
per-subject composite endpoint of cardiovascular death, target vessel MI, and clinically-indicated target vessel revascularization
Time Frame
30 days
Title
Target Vessel Failure
Description
per-subject composite endpoint of cardiovascular death, target vessel MI, and clinically-indicated target vessel revascularization
Time Frame
6 months
Title
Target Vessel Failure
Description
per-subject composite endpoint of cardiovascular death, target vessel MI, and clinically-indicated target vessel revascularization
Time Frame
12 months
Title
Target Vessel Failure
Description
per-subject composite endpoint of cardiovascular death, target vessel MI, and clinically-indicated target vessel revascularization
Time Frame
2 years
Title
Target Vessel Failure
Description
per-subject composite endpoint of cardiovascular death, target vessel MI, and clinically-indicated target vessel revascularization
Time Frame
3 years
Title
Late Lumen Loss
Description
powered secondary endpoint assessed by QCA in a subset of patients
Time Frame
6 months
Title
Optical Coherence Tomography (OCT) imaging
Description
assessment of the lesion and stent in a subset of patients.
Time Frame
Post procedure and 6 months
Title
Pharmacokinetic profile of the drugs on the DESyne BDS Plus Stent
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) 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. Exclusion Criteria: 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% 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Verheye, MD, PHD
Organizational Affiliation
Ziekenhuis Netwerk Antwerpen (ZNA) Middelheim, Antwerp, Belgium
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Webster, MBChB
Organizational Affiliation
Auckland City Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
ZNA Middelheim
City
Antwerp
ZIP/Postal Code
2020
Country
Belgium
Facility Name
AZ Sint Jan Brugge Oostende AV
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Ziekenhuis Oost-Limburg, Campus Sint Jan
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Universitaire Ziekenhuizen Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Instituto Dante Pazzanese
City
São Paulo
ZIP/Postal Code
04012-909
Country
Brazil
Facility Name
Instituto do Coração da Faculdade
City
São Paulo
ZIP/Postal Code
05403
Country
Brazil
Facility Name
General University Hospital
City
Prague
ZIP/Postal Code
12808
Country
Czechia
Facility Name
Catharina Hospital
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
North Shore Hospital
City
Auckland
ZIP/Postal Code
0622
Country
New Zealand
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Middlemore Hospital
City
Auckland
ZIP/Postal Code
2025
Country
New Zealand
Facility Name
Christchurch Hospital
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Dunedin Hospital
City
Dunedin
ZIP/Postal Code
9016
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
3240
Country
New Zealand

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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