Phase 2
Completed N=184
Clinical Investigation of the MiStent Drug Eluting Stent (DES) in Coronary Artery Disease
Source: ClinicalTrials.gov NCT01294748 ↗Enrolled (actual)
184
Serious AEs
39.1%
Results posted
Mar 2014
Primary outcomePrimary: In-Stent Late Lumen Loss — 0.27; 0.58 mm
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY In-Stent Late Lumen Loss |
0.27; 0.58 | — |
| PRIMARY Major Adverse Cardiac Events (MACE) |
4.3; 6.7 | — |
| SECONDARY Device Success |
100; 100 | — |
| SECONDARY Lesion Success |
100; 100 | — |
| SECONDARY Procedural Success |
98.4; 96.7 | — |
| SECONDARY Total Mortality |
0.9; 1.7 | — |
| SECONDARY Total Myocardial Infarct (MI) |
2.6; 3.3 | — |
| SECONDARY Clinically-driven Target Lesion Revascularization (TVR) |
0.9; 3.3 | — |
| SECONDARY Target Vessel Failure (TVF) |
3.4; 6.7 | — |
| SECONDARY Target Lesion Failure (TLF) |
1.7; 3.3; 2.5; 5; 3.4; 5 | — |
| SECONDARY Stent Thrombosis (Definite/Probable) |
0; 1.7 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥18 and ≤85 years;
- Stable/unstable angina pectoris (Class I-IV), documented ischemia/silent ischemia;
- Planned single, de novo, types A, B1 or B2 coronary lesions;
- Target lesion located in a native coronary artery;
- Target lesion in vessel ranging from 2.5 to 3.5 mm amenable to treatment (coverage) with a 30 mm long stent;
- Target lesion with >50% diameter stenosis;
- Recent Q-wave (>72 hours) or non-Q-wave myocardial infarction;
- Patients eligible for PCI;
- Candidate for CABG ;
- A patient may have one additional critical non-target lesion.
- Patient capable of providing informed consent and is willing to comply with all study requirements.
Exclusion Criteria
- 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;
- Recent Q-wave MI 2.0 mg/dL or 177 µmol/L);
- Platelet count 700,000 cells/mm³;
- White blood cell count 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:
- Located within the target vessel;
- Located within a bypass graft ;
- Left main location;
- Chronic total occlusion
- Involves a complex bifurcation.
Data sourced from ClinicalTrials.gov (NCT01294748). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.