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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03634020




Registration number
NCT03634020
Ethics application status
Date submitted
1/08/2018
Date registered
16/08/2018
Date last updated
9/12/2019

Titles & IDs
Public title
DynamX Sirolimus StudySirolimus Eluting Coronary Bioadaptor System
Scientific title
Evaluation of a Thin Strut Metallic Coronary Device: the Elixir DynamXTM Sirolimus Eluting Coronary Bioadaptor System
Secondary ID [1] 0 0
ELX-CL-1801
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
Treatment: Devices - DynamX Sirolimus-eluting Coronary Bioadaptor System

Experimental: DynamX Sirolimus-eluting Coronary Bioadaptor System - 2.5 - 3.5mm 14mm, 18mm and 28mm


Treatment: Devices: DynamX Sirolimus-eluting Coronary Bioadaptor System
de novo native coronary artery lesions

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Target Lesion (s) Failure - composite endpoint of cardiac death, target vessel MI and clinically-indicated TLR
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Target Lesion (s) Failure - composite endpoint of cardiac death, target vessel MI and clinically-indicated TLR
Timepoint [1] 0 0
1 month
Secondary outcome [2] 0 0
Target Lesion (s) Failure - composite endpoint of cardiac death, target vessel MI and clinically-indicated TLR
Timepoint [2] 0 0
12 month
Secondary outcome [3] 0 0
cardiac death - death from a cardiac cause
Timepoint [3] 0 0
1 month
Secondary outcome [4] 0 0
Cardiac Death - death from a cardiac cause
Timepoint [4] 0 0
6 months
Secondary outcome [5] 0 0
Cardiac Death - death from a cardiac cause
Timepoint [5] 0 0
12 months
Secondary outcome [6] 0 0
Non-Cardiac Death - death from a non-cardiac cause
Timepoint [6] 0 0
1 month
Secondary outcome [7] 0 0
Non-Cardiac Death - death from a non-cardiac cause
Timepoint [7] 0 0
6 months
Secondary outcome [8] 0 0
Non-Cardiac Death - death from a non-cardiac cause
Timepoint [8] 0 0
12 months
Secondary outcome [9] 0 0
myocardial infarction - all
Timepoint [9] 0 0
1 month
Secondary outcome [10] 0 0
myocardial infarction - all
Timepoint [10] 0 0
6 months
Secondary outcome [11] 0 0
myocardial infarction - all
Timepoint [11] 0 0
12 months
Secondary outcome [12] 0 0
myocardial infarction - related to the target vessel
Timepoint [12] 0 0
1 month
Secondary outcome [13] 0 0
myocardial infarction - related to the target vessel
Timepoint [13] 0 0
6 months
Secondary outcome [14] 0 0
Target Lesion Revascularization - Clinically indicated repeat intervention within the target lesion
Timepoint [14] 0 0
1 month
Secondary outcome [15] 0 0
Target Lesion Revascularization - Clinically indicated repeat intervention within the target lesion
Timepoint [15] 0 0
6 months
Secondary outcome [16] 0 0
Target Lesion Revascularization - Clinically indicated repeat intervention within the target lesion
Timepoint [16] 0 0
12 months
Secondary outcome [17] 0 0
Target Vessel Revascularization - Clinically indicated repeat intervention within the target vessel
Timepoint [17] 0 0
1 month
Secondary outcome [18] 0 0
Target Vessel Revascularization - Clinically indicated repeat intervention within the target vessel
Timepoint [18] 0 0
6 months
Secondary outcome [19] 0 0
Target Vessel Revascularization - Clinically indicated repeat intervention within the target vessel
Timepoint [19] 0 0
12 months
Secondary outcome [20] 0 0
Device Thrombosis - definite and probable as classified by an Academic Research Consortium
Timepoint [20] 0 0
1 month
Secondary outcome [21] 0 0
Device Thrombosis - definite and probable as classified by an Academic Research Consortium
Timepoint [21] 0 0
6 months
Secondary outcome [22] 0 0
Device Thrombosis - definite and probable as classified by an Academic Research Consortium
Timepoint [22] 0 0
12 months

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 DynamX Sirolimus Eluting CBS and provide written informed consent, as
approved by the NZ Ethics Committee, prior to any clinical study-related procedure

3. 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)

4. Patient must be an acceptable candidate for coronary artery bypass graft (CABG)
surgery

5. Women of childbearing potential with a negative pregnancy test within 7 days and women
who are not pregnant or nursing

6. Patient must agree to undergo all clinical study required follow up visits,
angiograms, and imaging testing

7. Patient must agree not to participate in any other clinical research study for a
period of one year following the index procedure Angiographic inclusion criteria-
Target Lesion/Vessel

8. Target lesion(s) must be located in a native coronary artery with a vessel diameter of
= 2.5 and =3.5 mm assessed visually or by online QCA

9. Target lesion(s) must measure = 24 mm in length

10. Target lesion(s) must be in a major artery or branch with a visually estimated
stenosis of = 50% and < 90% with a TIMI flow of = 2. When two target lesions are
treated, they must be located in separate major epicardial vessels

11. The lesion(s) must be successfully pre-dilated (less than 35% DS) prior to enrollment

12. The target lesion length is 24 mm and able to be covered by a single DynamX Sirolimus
Bioadaptor with 2 mm of healthy vessel on either side of planned implantation site

13. Treatment of a single, non-target lesion located in a separate major epicardial vessel
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient has a diagnosis of ST elevation myocardial infarction (STEMI) within 72 hours
preceding the index procedure, and CK and CK-MB have not returned within normal limits
at the time of procedure

2. Patient requires the use of rotational atherectomy during the index procedure

3. Patient has current unstable ventricular arrhythmias

4. Patient has a known left ventricular ejection fraction (LVEF) < 30%

5. Patient has received a heart transplant or any other organ transplant or is on a
waiting list for an organ transplant

6. Patient is receiving or scheduled to receive chemotherapy for malignancy within 30
days prior to or after the procedure

7. Patient is receiving immunosuppression therapy, other than steroids or has known
immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic
lupus erythematosus etc.)

8. Patient has a known hypersensitivity or contraindication to aspirin, both heparin and
bivalirudin, clopidogrel, prasugrel or ticagrelor, Sirolimus, CoCr alloys, PLLA
polymers or contrast sensitivity that cannot be adequately pre-medicated

9. Elective surgery is planned within the first 6 months after the procedure that will
require discontinuing either aspirin or clopidogrel or other P2Y12 inhibitors.

10. Patient has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a WBC of <
3,000 cells/mm3, or documented liver disease.

11. Patient has severe renal dysfunction (CKD IV or V, eGFR <30) or is on dialysis.

12. Patient has a history of bleeding diathesis or coagulopathy or will refuse blood
transfusions

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. Patient has a condition that precludes safe 6 French sheath insertion; or 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 associated with a limited life expectancy (i.e., less than one year)

16. Patient is already participating in another clinical study which has not reached the
primary endpoint (long-term follow-up is not an exclusion) Angiographic Exclusion
Criteria Target Lesion/Vessel

1. Target/Vessel / Target lesion(s) meets any of the following criteria:

1. Aorto-ostial location

2. Left main location

3. Located within 5 mm of the origin of the LAD or LCX

4. Located within an arterial or saphenous vein graft or distal to a diseased arterial or
saphenous vein graft

5. Lesion involving a bifurcation with a side branch >2mm in diameter

6. Previous placement of a stent within 10 mm of the target lesion

7. Total or sub-total occlusion (TIMI flow =1)

8. The proximal target vessel or target lesion is severely calcified by visual
assessment, or the lesion prevents full pre-dilatation balloon expansion

9. Previous intervention restenosis 2. The target vessel contains visible thrombus 3.
Another clinically-significant lesion (>50%) is located in the same major epicardial
vessel as the target lesion 5. Target vessel was previously treated with any type of
PCI < 6 months prior to index procedure 6. Non-Target vessel was previously treated
with any type of PCI < 30 days prior to the index procedure

Study design
Purpose of the study
Treatment
Allocation to intervention
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
New Zealand
State/province [3] 0 0
Dunedin
Country [4] 0 0
New Zealand
State/province [4] 0 0
Hamilton
Country [5] 0 0
New Zealand
State/province [5] 0 0
Wellington

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

Ethics approval
Ethics application status

Summary
Brief summary
To confirm the safety and performance of the DynamX Sirolimus-eluting Coronary Bioadaptor
System (SECBS) in de novo native coronary artery lesions using clinical and imaging
endpoints. Clinical follow-up will be conducted in all patients at 30 days, 6 and 12 months.
Imaging follow-up will be conducted at 6 months.
Trial website
https://clinicaltrials.gov/show/NCT03634020
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Stephanie Simpson-Plaumann
Address 0 0
Country 0 0
Phone 0 0
+33 6 58473696
Fax 0 0
Email 0 0
ssplaumann@elixirmedical.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03634020