Clinical trial NCT01247428: First-In-Human Trial of the MiStent Drug-Eluting Stent (DES) in Coronary Artery Disease
Official title: A First-In-Human Trial of a New Novel DES (MiStent System) With Sirolimus and a Bioabsorbable Polymer for the Treatment of Patients With De Novo Lesions in the Native Coronary Arteries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
Drug-eluting Stent
Sirolimus
Lead sponsor: Micell Technologies
Sponsor class: INDUSTRY
First posted: 2010-11-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Angiographic In-Stent Late Lumen Loss
timeFrame: 8 months
Secondary outcomes:
measure: Percentage of Participants Experiencing Major Adverse Cardiac Events (MACE)
timeFrame: 240 days
measure: Device Success
timeFrame: 8 hours
measure: Lesion Success
timeFrame: 8 hours
measure: Procedural Success
timeFrame: 8 hours
measure: Total Mortality
timeFrame: 240 days
measure: Total Myocardial Infarction (MI)
timeFrame: 240 days
measure: Clinically-driven Target Lesion Revascularization (TLR) Rates
timeFrame: 240 days
measure: Clinically-driven Target Vessel Revascularization (TVR) Rates
timeFrame: 240 days
measure: Target Vessel Failure (TVF)
timeFrame: 240 days
measure: Target Lesion Failure (TLF)
timeFrame: 240 days
measure: Stent Thrombosis
timeFrame: 240 days
measure: Angiographic Evaluation: In-stent Binary Restenosis
timeFrame: 4 months, 6 months, 8 months
measure: Angiographic Evaluation: In-stent Binary Restenosis
timeFrame: 18 months
measure: Intravascular Ultrasound (IVUS) Evaluation: % Neointimal Volume Obstruction
timeFrame: 8 months
measure: IVUS Evaluation: % Neointimal Volume Obstruction
timeFrame: 18 months
measure: Optical Coherence Tomography (OCT) Evaluation: % Stent Strut Uncovered
timeFrame: 8 months
measure: OCT Evaluation: % Stent Strut Uncovered
timeFrame: 18 M
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: St. Vincent's Hospital Melbourne
city: Aalst
country: Belgium
facility: Onze-Lieve-Vrouwziekenhuis Aalst (OLV Hospital)
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Aukland
country: New Zealand
facility: Mercy Angiography Unit - Mercy Hospital
Study officials:
affiliation: Cardiovascular Center, Onze-Lieve-Vrouwziekenhuis Aalst (OLV Hospital)
name: William Wijns, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mercy Angiography Unit
name: John Ormiston, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ormiston J, Webster M, Stewart J, Vrolix M, Whitbourn R, Donohoe D, Knape C, Lansky A, Attizzani GF, Fitzgerald P, Kandzari DE, Wijns W. First-in-human evaluation of a bioabsorbable polymer-coated sirolimus-eluting stent: imaging and clinical results of the DESSOLVE I Trial (DES with sirolimus and a bioabsorbable polymer for the treatment of patients with de novo lesion in the native coronary arteries). JACC Cardiovasc Interv. 2013 Oct;6(10):1026-34. doi: 10.1016/j.jcin.2013.05.013. Epub 2013 Sep 18.
citation: Attizzani GF, Bezerra HG, Ormiston J, Wang W, Donohoe D, Wijns W, Costa MA. Serial assessment by optical coherence tomography of early and late vascular responses after implantation of an absorbable-coating Sirolimus-Eluting stent (from the first-in-human DESSOLVE I trial). Am J Cardiol. 2013 Nov 15;112(10):1557-64. doi: 10.1016/j.amjcard.2013.07.013. Epub 2013 Aug 29.