Clinical Investigation of the MiStent Drug Eluting Stent (DES) in Coronary Artery Disease (DESSOLVE-II)

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, Drug-eluting Stent, Sirolimus Read More

Inclusion Criteria:

1. Age ≥18 and ≤85 years;
2. Stable/unstable angina pectoris (Class I-IV), documented ischemia/silent ischemia;
3. Planned single, de novo, types A, B1 or B2 coronary lesions;
4. Target lesion located in a native coronary artery;
5. Target lesion in vessel ranging from 2.5 to 3.5 mm amenable to treatment (coverage) with a 30 mm long stent;
6. Target lesion with >50% diameter stenosis;
7. Recent Q-wave (>72 hours) or non-Q-wave myocardial infarction;
8. Patients eligible for PCI;
9. Candidate for CABG ;
10. A patient may have one additional critical non-target lesion.
11. Patient capable of providing informed consent and is willing to comply with all study requirements.

Exclusion Criteria:

1. Female patients of childbearing potential who do not have a confirmed negative pregnancy test at baseline and are not on some form of birth control;
2. Recent Q-wave MI < 72 hours prior to the index procedure.
3. Recent Q- or non-Q-wave MI with still elevated levels of cardiac markers (e.g. CK; and CK-MB if the CK is elevated);
4. LVEF <30% (within the previous 6-months);
5. Patients in cardiogenic shock;
6. CVA or TIA within the past 6 months;
7. Active GI bleeding within past 3 months;
8. Any prior anaphylactic reaction to contrast agents;
9. Chemotherapy within 30-days before or after the index procedure;
10. Receiving oral or intravenous immunosuppressive therapy or has known life-limiting immunosuppressive or autoimmune disease;
11. Renal dysfunction (creatinine > 2.0 mg/dL or 177 µmol/L);
12. Platelet count <100,000 cells/mm³ or >700,000 cells/mm³;
13. White blood cell count <3,000 cells/mm3;
14. Hepatic disease;
15. Heart transplant recipient;
16. Known contraindication to DAPT;
17. Known hypersensitivity to sirolimus, cobalt-chromium, or to medications such as aspirin, heparin and Angiomax (bivalirudin), and all three of the following: clopidogrel bisulfate (Plavix), ticlopidine (Ticlid), and Prasugrel (Effient);
18. Life expectancy less than 12 months;
19. Any major medical condition that may interfere with participation in this study;
20. Patient is currently participating in an investigational drug or another device study and has not completed the follow-up to the primary endpoint, or the patient is planning on participating prior to completing 12-months follow-up;
21. Target vessel has been treated within 10 mm proximal or distal to target lesion with any type of PCI or within a year prior to index procedure;
22. Planned or actual target vessel(s) treatment with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon, or transluminal extraction catheter prior to stent placement;
23. Patient previously treated at any time with brachytherapy;
24. Planned coronary angioplasty or CABG in the first 9 months after the index procedure or any other planned intervention within 30-days post index procedure;
25. Prior PCI of a non-target vessel must be at least 14 days prior to study enrollment;
26. The intent to direct stent the target lesion;

27. Angiographic Exclusion Criteria:

    • In-stent restenotic target lesion;
    • In-stent restenotic target lesion;
    • More than one lesion requiring treatment in the target vessel);
    • Target vessel diameter <2.5 mm or >3.5 mm;
    • Long target lesion not amenable to treatment with up to a 30 mm long stent;
    • Left main critical disease (≥50% DS);
    • Target lesion is located in a surgical bypass graft;
    • Total target vessel occlusion (TIMI flow grade 0-1);
    • Target lesion ostial location;
    • Target lesion at bifurcation involving side branch >2.5 mm or lateral branch that also requires stenting;
    • Calcified target lesion that anticipates unsuccessful/impracticable predilation;
    • Target vessel with excessive tortuosity or proximal angulation;
    • Thrombus present in target vessel;
    • More than one non-target critical lesion;

    • Non-target lesion to be treated during the index procedure meets any of the following criteria:

      1. Located within the target vessel;
      2. Located within a bypass graft ;
      3. Left main location;
      4. Chronic total occlusion
      5. Involves a complex bifurcation.