Status:
COMPLETED
First-In-Human Trial of the MiStent Drug-Eluting Stent (DES) in Coronary Artery Disease
Lead Sponsor:
Micell Technologies
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
The DESSOLVE I clinical trial is to assess the safety and performance of the sirolimus-eluting MiStent SES.
Detailed 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 h...
Eligibility Criteria
Inclusion
- 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
- 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 \<72 hours prior to the index procedure. Recent myocardial infarction with elevated levels of cardiac markers;
- Left ventricular ejection fraction \<30%;
- Patients in cardiogenic shock;
- Cerebrovascular accident or transient ischemic attack within 6 months;
- Active GI bleed within three months;
- Any prior true anaphylactic reaction to contrast agents;
- Patient receiving/scheduled to receive chemotherapy within 30-days before or after the index procedure;
- Patient is receiving immunosuppressive therapy or has known life-limiting immunosuppressive/autoimmune disease;
- Renal dysfunction (creatinine \> 2.0 mg/dL or 177 µmol/L);
- Platelet count \<100,000 cells/mm³ or \>700,000 cells/mm³;
- White blood cell count \<3,000 cells/mm3;
- Hepatic disease;
- Heart transplant recipient;
- Known contraindication to dual antiplatelet therapy;
- 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);
- Life expectancy \<12 months;
- Any major medical condition that may interfere with the optimal participation of the patient in this study;
- Patient is currently participating/planning to participate in an investigational drug or another device study prior to completing 12-months follow-up;
- 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;
- 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;
- Previous coronary intravascular brachytherapy;
- Planned coronary angioplasty or coronary artery bypass grafting (CABG)in the first 9 months after the index procedure;
- Prior PCI of a non-target vessel must be at least 30 days prior to study enrollment;
- The intent to direct stent the target lesion;
- Angiographic
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01247428
Start Date
November 1 2010
End Date
March 1 2016
Last Update
December 19 2016
Active Locations (5)
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1
St. Vincent's Hospital Melbourne
Melbourne, Australia
2
Onze-Lieve-Vrouwziekenhuis Aalst (OLV Hospital)
Aalst, Belgium
3
Ziekenhuis Oost-Limburg
Genk, Belgium
4
Auckland City Hospital
Auckland, New Zealand, 1032