Clinical Investigation 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 DES; Endeavor DES
Intervention description: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).; The Endeavor is a device/drug combination comprised of two components; a stent and a drug product (everolimus within a durable polymer coating).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 184.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Coronary Artery Disease; Drug-eluting Stent; Sirolimus

Summary:

      The DESSOLVE II clinical trial is to assess the safety and performance of the
      sirolimus-eluting MiStent for the treatment for improving coronary luminal diameter in
      patients with symptomatic ischemic heart disease due to discrete de novo lesions in the
      native coronary arteries.
    

Eligibility criteria:

        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.