Drug-Eluting Stent Study Evaluating a New Technology in Patients with Symptomatic Ischemic Heart Disease due to Coronary Artery Blockage

Phase 1

Completed

• Conditions: Coronary Artery Disease; Symptomatic Ischemic Heart Disease; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12611001131943
• Lead Sponsor: Svelte Medical Systems, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-28
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

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.

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

• Study Type: Interventional
• Study Design: Not specified