First-In-Human Trial of the MiStent Drug-Eluting Stent (DES) in Coronary Artery Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: MiStent SES
Intervention description: The MiStent SES is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Coronary Artery Disease; Drug-eluting Stent; Sirolimus

Summary:

      The DESSOLVE I clinical trial is to assess the safety and performance of the
      sirolimus-eluting MiStent SES.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male/female patients 18-85 years;

          2. Stable or unstable angina pectoris, ischemia, or silent ischemia;

          3. Planned single, de novo, types A, B1 and B2 coronary lesions;

          4. Target lesion located in a native coronary artery;

          5. Target lesion vessel diameter 2.5 to 3.5 mm amenable to treatment with a maximum 23 mm
             long stent;

          6. Target lesion >50% diameter stenosis;

          7. Patients eligible for percutaneous coronary intervention (PCI);

          8. Acceptable candidate for myocardial revascularization surgery;

          9. A patient may have one additional critical non-target lesion.

         10. The patient will provide written informed consent.

        Exclusion Criteria:

          1. Female of childbearing potential not on some form of birth control with a confirmed
             negative pregnancy test at baseline;

          2. Recent Q-wave myocardial infarction occurred <72 hours prior to the index procedure.
             Recent myocardial infarction with elevated levels of cardiac markers;

          3. Left ventricular ejection fraction <30%;

          4. Patients in cardiogenic shock;

          5. Cerebrovascular accident or transient ischemic attack within 6 months;

          6. Active GI bleed within three months;

          7. Any prior true anaphylactic reaction to contrast agents;

          8. Patient receiving/scheduled to receive chemotherapy within 30-days before or after the
             index procedure;

          9. Patient is receiving immunosuppressive therapy or has known life-limiting
             immunosuppressive/autoimmune disease;

         10. Renal dysfunction (creatinine > 2.0 mg/dL or 177 µmol/L);

         11. Platelet count <100,000 cells/mm³ or >700,000 cells/mm³;

         12. White blood cell count <3,000 cells/mm3;

         13. Hepatic disease;

         14. Heart transplant recipient;

         15. Known contraindication to dual antiplatelet therapy;

         16. Known hypersensitivity to sirolimus, cobalt-chromium, or to medications such as
             aspirin, heparin, and all three of the following: clopidogrel bisulfate (Plavix),
             ticlopidine (Ticlid), and Prasugrel (Effient);

         17. Life expectancy <12 months;

         18. Any major medical condition that may interfere with the optimal participation of the
             patient in this study;

         19. Patient is currently participating/planning to participate in an investigational drug
             or another device study prior to completing 12-months follow-up;

         20. Target vessel(s) has been treated within 10 mm proximal or distal to target lesion
             with any type of PCI within a year prior to index procedure;

         21. 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;

         22. Previous coronary intravascular brachytherapy;

         23. Planned coronary angioplasty or coronary artery bypass grafting (CABG)in the first 9
             months after the index procedure;

         24. Prior PCI of a non-target vessel must be at least 30 days prior to study enrollment;

         25. The intent to direct stent the target lesion;

         26. Angiographic Exclusion Criteria: Assessed prior to stent placement;

               -  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;

               -  Target lesion not amenable to treatment with a 23 mm long stent;

               -  Unprotected coronary artery branch lesion (≥50% DS);

               -  Target lesion located in a surgical bypass graft;

               -  Total vessel occlusion;

               -  Target lesion with ostial location;

               -  Target lesion located in a lateral branch bifurcation >2.5mm or requiring lateral
                  branch stenting;

               -  Calcified target lesion that anticipates unsuccessful/impracticable predilation;

               -  Target vessel excessive tortuosity or proximal angulation (>90 degrees);

               -  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:

          -  Within the target vessel;

          -  Within a bypass graft;

          -  Left main location;

          -  Chronic total occlusion;

          -  Involves a complex bifurcation.