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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01247428
Registration number
NCT01247428
Ethics application status
Date submitted
18/11/2010
Date registered
24/11/2010
Date last updated
19/12/2016
Titles & IDs
Public title
First-In-Human Trial of the MiStent Drug-Eluting Stent (DES) in Coronary Artery Disease
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Scientific 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
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Secondary ID [1]
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MIS-FIH-2010-01
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Universal Trial Number (UTN)
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Trial acronym
DESSOLVE-I
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - MiStent SES
Experimental: MiStent SES - 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: Devices: MiStent SES
The MiStent SES is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Angiographic In-Stent Late Lumen Loss
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Assessment method [1]
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In-stent late lumen loss as measured by the angiographic core laboratory as the difference between the post-procedure minimal lumen diameters (MLD) in the treated segment (stented region) minus the MLD in the same region at follow-up.
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Timepoint [1]
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8 months
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Secondary outcome [1]
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Percentage of Participants Experiencing Major Adverse Cardiac Events (MACE)
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Assessment method [1]
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Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q-wave and non-Q-wave) and target vessel revascularization (TVR)
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Timepoint [1]
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240 days
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Secondary outcome [2]
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Device Success
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Assessment method [2]
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Achievement of a final in-stent residual diameter stenosis of <50% (by QCA), using the assigned device only
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Timepoint [2]
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8 hours
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Secondary outcome [3]
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Lesion Success
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Assessment method [3]
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Achievement of a final in-stent residual diameter stenosis of <50% (by QCA) using any percutaneous method
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Timepoint [3]
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8 hours
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Secondary outcome [4]
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Procedural Success
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Assessment method [4]
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Achievement of a final in-stent residual diameter stenosis of <50% (by QCA) using the assigned device (including any adjunctive devices) without cardiac death, Myocardial infarction (MI) or repeat revascularization of the target lesion pre-hospital discharge
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Timepoint [4]
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8 hours
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Secondary outcome [5]
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Total Mortality
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Assessment method [5]
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Total mortality (cardiac and non-cardiac)
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Timepoint [5]
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240 days
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Secondary outcome [6]
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Total Myocardial Infarction (MI)
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Assessment method [6]
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Q-wave MI (QWMI): requires one of the following criteria: the development of new abnormal Q waves in =2 contiguous ECG leads not present on the patient's baseline (i.e., before intervention) in association with a >2x upper limit normal elevation of creatine kinase (CK) levels. In the absence of ECG data, the clinical events committee may adjudicate a Q-wave MI based on the clinical scenario and appropriate cardiac enzyme data; chest pain or other acute symptoms consistent with myocardial ischemia and new pathological Q waves in =2 contiguous ECG leads in the absence of timely cardiac enzyme data.
Non-Q-wave MI (NQWMI): the elevation of CK levels (=2 times ULN) with elevated CK-MB enzyme levels in the absence of new pathologic Q waves.
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Timepoint [6]
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240 days
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Secondary outcome [7]
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Clinically-driven Target Lesion Revascularization (TLR) Rates
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Assessment method [7]
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A revascularization is considered clinically driven if angiography at follow-up shows a percent diameter stenosis = 50% (Angiographic Core Laboratory QCA assessment) and if one of the following occurs:
A positive history of recurrent angina pectoris, presumably related to the target vessel;
Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve);
A target lesion revascularization (TLR) with a diameter stenosis = 70% even in the absence of the above-mentioned ischemic signs or symptoms.
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Timepoint [7]
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240 days
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Secondary outcome [8]
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Clinically-driven Target Vessel Revascularization (TVR) Rates
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Assessment method [8]
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A revascularization is considered clinically driven if angiography at follow-up shows a percent diameter stenosis = 50% (Angiographic Core Laboratory QCA assessment) and if one of the following occurs:
A positive history of recurrent angina pectoris, presumably related to the target vessel;
Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve);
A target vessel revascularization (TVR) with a diameter stenosis = 70% even in the absence of the above-mentioned ischemic signs or symptoms.
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Timepoint [8]
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240 days
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Secondary outcome [9]
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Target Vessel Failure (TVF)
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Assessment method [9]
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Target vessel failure (TVF) is defined as the composite endpoint of:
cardiac death,
target-vessel myocardial infarction (Q wave or non-Q wave), and
clinically indicated target vessel revascularization
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Timepoint [9]
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240 days
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Secondary outcome [10]
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Target Lesion Failure (TLF)
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Assessment method [10]
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Target lesion failure (TLF) is defined as the composite endpoint of:
cardiac death,
target-lesion myocardial infarction (Q wave or non-Q wave), and
clinically indicated target lesion revascularization
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Timepoint [10]
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240 days
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Secondary outcome [11]
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Stent Thrombosis
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Assessment method [11]
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The presence of an intracoronary thrombus that originates in the stent or in the segments 5 mm proximal or distal to the stent post-procedure
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Timepoint [11]
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240 days
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Secondary outcome [12]
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Angiographic Evaluation: In-stent Binary Restenosis
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Assessment method [12]
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Binary Restenosis is defined as =50% luminal narrowing at follow-up angiography.
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Timepoint [12]
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4 months, 6 months, 8 months
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Secondary outcome [13]
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Angiographic Evaluation: In-stent Binary Restenosis
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Assessment method [13]
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Binary Restenosis is defined as =50% luminal narrowing at follow-up angiography.
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Timepoint [13]
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18 months
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Secondary outcome [14]
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Intravascular Ultrasound (IVUS) Evaluation: % Neointimal Volume Obstruction
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Assessment method [14]
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% neointimal volume obstruction is defined as the neointimal volume divided by stent volume.
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Timepoint [14]
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8 months
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Secondary outcome [15]
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IVUS Evaluation: % Neointimal Volume Obstruction
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Assessment method [15]
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% neointimal volume obstruction is defined as the neointimal volume divided by stent volume.
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Timepoint [15]
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18 months
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Secondary outcome [16]
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Optical Coherence Tomography (OCT) Evaluation: % Stent Strut Uncovered
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Assessment method [16]
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% stent strut uncovered is defined as the ratio of uncovered struts to total struts in all cross-sections.
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Timepoint [16]
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8 months
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Secondary outcome [17]
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OCT Evaluation: % Stent Strut Uncovered
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Assessment method [17]
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% stent strut uncovered is defined as the ratio of uncovered struts to total struts in all cross-sections.
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Timepoint [17]
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18 M
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
85
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2016
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Sample size
Target
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Accrual to date
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Final
30
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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St. Vincent's Hospital Melbourne - Melbourne
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Recruitment postcode(s) [1]
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- Melbourne
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Recruitment outside Australia
Country [1]
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Belgium
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State/province [1]
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Aalst
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Country [2]
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Belgium
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State/province [2]
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Genk
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Country [3]
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New Zealand
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State/province [3]
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Auckland
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Country [4]
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New Zealand
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State/province [4]
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Aukland
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Micell Technologies
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The DESSOLVE I clinical trial is to assess the safety and performance of the
sirolimus-eluting MiStent SES.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01247428
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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William Wijns, MD
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Address
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Cardiovascular Center, Onze-Lieve-Vrouwziekenhuis Aalst (OLV Hospital)
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01247428
Download to PDF