First-In-Human Trial of the MiStent Drug-Eluting Stent (DES) in Coronary Artery Disease (DESSOLVE-I)

Micell Technologies

Status and phase: Completed; Phase 2

Conditions: Coronary Artery Disease

Treatments: Device: MiStent SES

Study type: Interventional

Funder types: Industry

Identifiers

NCT01247428

MIS-FIH-2010-01

Details and patient eligibility

About

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

Full description

The DESSOLVE I 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 < 20 mm in length in the native coronary arteries with reference vessel diameters between 2.5 mm and 3.5 mm.

Enrollment: 30 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

MiStent SES

Experimental group

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).

Treatment:

Device: MiStent SES