Phase 2
Completed N=30
First-In-Human Trial of the MiStent Drug-Eluting Stent (DES) in Coronary Artery Disease
Source: ClinicalTrials.gov NCT01247428 ↗Enrolled (actual)
30
Serious AEs
23.3%
Results posted
Jun 2014
Primary outcomePrimary: Angiographic In-Stent Late Lumen Loss — 0.09 mm
Summary
The DESSOLVE I clinical trial is to assess the safety and performance of the sirolimus-eluting MiStent SES.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Angiographic In-Stent Late Lumen Loss |
0.09 | — |
| SECONDARY Percentage of Participants Experiencing Major Adverse Cardiac Events (MACE) |
3.3 | — |
| SECONDARY Device Success |
96.67 | — |
| SECONDARY Lesion Success |
100 | — |
| SECONDARY Procedural Success |
100 | — |
| SECONDARY Total Mortality |
— | — |
| SECONDARY Total Myocardial Infarction (MI) |
3.3 | — |
| SECONDARY Clinically-driven Target Lesion Revascularization (TLR) Rates |
— | — |
| SECONDARY Clinically-driven Target Vessel Revascularization (TVR) Rates |
— | — |
| SECONDARY Target Vessel Failure (TVF) |
— | — |
| SECONDARY Target Lesion Failure (TLF) |
— | — |
| SECONDARY Stent Thrombosis |
— | — |
| SECONDARY Angiographic Evaluation: In-stent Binary Restenosis |
— | — |
| SECONDARY Intravascular Ultrasound (IVUS) Evaluation: % Neointimal Volume Obstruction |
8.0 | — |
| SECONDARY IVUS Evaluation: % Neointimal Volume Obstruction |
11.2 | — |
| SECONDARY Optical Coherence Tomography (OCT) Evaluation: % Stent Strut Uncovered |
3.8 | — |
| SECONDARY OCT Evaluation: % Stent Strut Uncovered |
— | — |
Eligibility Criteria
Inclusion Criteria
- Male/female patients 18-85 years;
- Stable or unstable angina pectoris, ischemia, or silent ischemia;
- Planned single, de novo, types A, B1 and B2 coronary lesions;
- Target lesion located in a native coronary artery;
- Target lesion vessel diameter 2.5 to 3.5 mm amenable to treatment with a maximum 23 mm long stent;
- Target lesion >50% diameter stenosis;
- Patients eligible for percutaneous coronary intervention (PCI);
- Acceptable candidate for myocardial revascularization surgery;
- A patient may have one additional critical non-target lesion.
- The patient will provide written informed consent.
Exclusion Criteria
- Female of childbearing potential not on some form of birth control with a confirmed negative pregnancy test at baseline;
- Recent Q-wave myocardial infarction occurred 2.0 mg/dL or 177 µmol/L);
- Platelet count 700,000 cells/mm³;
- White blood cell count 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.
Data sourced from ClinicalTrials.gov (NCT01247428). 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.