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Trial registered on ANZCTR


Registration number
ACTRN12611001131943
Ethics application status
Approved
Date submitted
27/10/2011
Date registered
28/10/2011
Date last updated
11/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Drug-Eluting Stent Study Evaluating a New Technology in Patients with Symptomatic Ischemic Heart Disease due to Coronary Artery Blockage
Scientific title
Evaluating the Svelte Drug Eluting Stent-on-a-Wire (DESOAW) in Patients with Symptomatic Ischemic Heart Disease due to Coronary Artery Blockage
Secondary ID [1] 273284 0
Nil known
Universal Trial Number (UTN)
U1111-1125-5051
Trial acronym
DIRECT I FIM Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 279047 0
Symptomatic Ischemic Heart Disease 279048 0
Condition category
Condition code
Cardiovascular 279237 279237 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The percutaneous revascularization of native coronary arteries exhibiting stenotic lesion(s) using a novel sirolimus-eluting cobalt chromium stent with bioerodable drug carrier delivered via fixed-wire catheter system is similar to current stenting procedures. Depending on difficulty of lesion treatment, procedures, typcially under conscious sedation, take between 30 and 90 minutes and are conducted in the cardiology cath lab. A small puncture in the groin or arm provides arterial access to place a stent in the heart using x-ray fluoroscopy for visualization during the procedure. Ususally this is a one-time procedure; however, some patients experience re-clogging of the target artery and have to return for reinitervention.
Intervention code [1] 283630 0
Treatment: Devices
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279863 0
Angiographic target vessel failure
Timepoint [1] 279863 0
6 months post procedure
Primary outcome [2] 279864 0
Angiographic in-Stent Late Lumen Loss
Timepoint [2] 279864 0
6 months post procedure
Secondary outcome [1] 294606 0
Clinically-driven target lesion revascularization
Timepoint [1] 294606 0
1 and 6 months and yearly through 5 years post-procedure
Secondary outcome [2] 294607 0
Composite of cardiac death, MI attributed to the target vessel revascularization
Timepoint [2] 294607 0
1 and 6 months post-procedure, and yearly up to 5 years
Secondary outcome [3] 294608 0
Stent thrombosis as determined by the attending physician
Timepoint [3] 294608 0
1 and 6 months and yearly for5 years post-procedure
Secondary outcome [4] 294609 0
In-stent and in-segment angiographic binary restenosis
Timepoint [4] 294609 0
6 months post procedure
Secondary outcome [5] 294610 0
In-stent and in-segment minimum lumen diameter as assessed by IVUS
Timepoint [5] 294610 0
6 months post-procedure
Secondary outcome [6] 294611 0
In-segment late lumen loss as assessed by IVUS
Timepoint [6] 294611 0
6 months post-procedure
Secondary outcome [7] 294612 0
Neointimal hyperplasia (% lumen volume) measured by Intravascular Ultrasound (IVUS)
Timepoint [7] 294612 0
6 months post-procedure
Secondary outcome [8] 294613 0
Strut coverage (% of struts malapposed, protruding non-covered, protruding covered, non-protruding covered) measured by optical coherence tomography (OCT)
Timepoint [8] 294613 0
6 months post-procedure

Eligibility
Key inclusion criteria
1. Patient is at least 18 years old;

2. Patient is eligible for percutaneous coronary intervention (PCI) and an acceptable candidate for emergent coronary artery bypass graft (CABG) surgery;

3. Patient has clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, and/or a positive functional study;

4. Patient has either a single target lesion, or two lesions (target and non-target) located in separate coronary arteries;

5. Reference vessel of 2.5 mm through 3.5 mm in diameter by visual estimate;

6. Target lesion less than 20 mm in length by visual estimate (the intention should be to cover the whole lesion with one stent of adequate length);

7. Target lesion stenosis between 50% and 100% by visual estimate.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient is currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints;

2. The patient requires a staged procedure of the target vessel within 6 months or a staged procedure of a non-target vessel within 30 days post-procedure;

3. The target lesion requires treatment with a device other than PTCA prior to stent placement (such as, but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.);

4. Any DES deployment anywhere in the target vessel within the past 9 months;

5. Any BMS deployment anywhere in the target vessel within the past 6 months;

6. Any previous stent placement within 10 mm (proximal or distal) of the target lesion;

7. Myocardial infarction within 72 hours of the index procedure, with the exception of:
a. Patients who have had a STEMI and PCI to the culprit lesion may be included if they have a suitable lesion in another vessel, and have been clinically and hemodynamically stable for 72 hours;
b. Patients who have had a non- STEMI may be included if their CK is within the laboratory normal range within 24 hours pre-procedure.

8. Co-morbid condition(s) that could limit the patient’s ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial;

9. Concurrent medical condition with a life expectancy of less than 12 months;

10. Documented left ventricular ejection fraction (LVEF) of at least 30%;

11. Unstable angina pectoris from an extra-cardiac cause (Braunwald Class A I-III);

12. Known allergies to the following: Acetylsalicylic acid (ASA), Clopidogrel bisulfate, Ticlopidine, Prasugrel, Rapamycin, PEAIII AcBz, Heparin/ Bivalirudin, or contrast agent (that cannot be adequately premedicated);

13. Platelet count = less than100,000 cells/mm3 or greater than 700,000 cells/mm3 or a WBC less than 3.000 cells/mm3 or hemoglobin less than 100g/l;

14. Acute or chronic renal dysfunction (serum creatinine greater than 170µmol/L);

15. History of a stroke or transient ischemic attack (TIA) within the prior 6 months;

16. Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months;

17. History of bleeding diathesis or coagulopathy or will refuse blood transfusions.

18. Patients requiring ongoing anticoagulation with warfarin or dabigatran.

19. Total occlusion (TIMI 0 or 1);

20. Target vessel has angiographic evidence of thrombus

21. Target vessel is excessively tortuous or has heavy calcification;

22. Significant ( greater than 50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run off;

23. Target lesion is located in or supplied by an arterial or venous bypass graft;

24. Ostial target lesion (within 5.0mm of vessel origin) or any location within the left main coronary artery;

25. Target lesion involves a side branch greater than 2.0mm in diameter;

26. Unprotected Left main coronary artery disease (stenosis greater than 50%).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Pateint qualifies based on study eligibility criteria; once enrolled, intention is to treat with study product for all patients.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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 outside Australia
Country [1] 3931 0
New Zealand
State/province [1] 3931 0
Auckland
Country [2] 3932 0
New Zealand
State/province [2] 3932 0
Christchurch
Country [3] 3933 0
New Zealand
State/province [3] 3933 0
Wellington

Funding & Sponsors
Funding source category [1] 284110 0
Commercial sector/Industry
Name [1] 284110 0
Svelte Medical Systems, Inc.
Address [1] 284110 0
675 Central Avenue
New Providence, New Jersey 07974
Country [1] 284110 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Svelte Medical Systems, Inc.
Address
675 Central Avenue
New Providence, New Jersey 07974
Country
United States of America
Secondary sponsor category [1] 269080 0
Commercial sector/Industry
Name [1] 269080 0
Svelte Medical Systems, Inc.
Address [1] 269080 0
675 Central Avenue
New Providence, New Jersey 07974
Country [1] 269080 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272062 0
Health and Disability Ethics Committees
Ethics committee address [1] 272062 0
Multi-Region Ethics Committee
Ministry of Health
No. 1 The Terrace
PO Box 5013
Wellington 6145
Ethics committee country [1] 272062 0
New Zealand
Date submitted for ethics approval [1] 272062 0
Approval date [1] 272062 0
19/10/2011
Ethics approval number [1] 272062 0
MEC/11/08/075

Summary
Brief summary
The objective of this trial is to assess the safety and clinical performance of the novel Svelte DESOAW Coronary Stent System with fully bioerodable drug carrier eluting the well-studied drug compound sirolimus in patients with single de novo coronary artery lesions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33321 0
Dr Mark Webster
Address 33321 0
Interventional Cardiology
Cardiac Investigations Unit
Level 3, Building 32
Auckland City Hospital
Private Bag 92-024
Auckland 1023
Country 33321 0
New Zealand
Phone 33321 0
+ 64 9 3074949 ext 24389
Fax 33321 0
Email 33321 0
MWebster@adhb.govt.nz
Contact person for public queries
Name 16568 0
Mr Richard Spencer
Address 16568 0
Svelte Medical Systems, Inc.
675 Central Avenue
New Providence, New Jersey 07974
Country 16568 0
United States of America
Phone 16568 0
+ 01 908 264 2856
Fax 16568 0
+ 01 908 728 9981
Email 16568 0
rspencer@sveltemedical.com
Contact person for scientific queries
Name 7496 0
Mr Richard Spencer
Address 7496 0
Svelte Medical Systems, Inc.
675 Central Avenue
New Providence, New Jersey 07974
Country 7496 0
United States of America
Phone 7496 0
+ 01 908 264 2856
Fax 7496 0
+ 01 908 728 9981
Email 7496 0
rspencer@sveltemedical.com

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary