Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01247428




Trial ID
NCT01247428
Ethics application status
Date submitted
18/11/2010
Date registered
23/11/2010
Date last updated
15/12/2016

Titles & IDs
Public title
First-In-Human Trial of the MiStent Drug-Eluting Stent (DES) in Coronary Artery Disease
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
Secondary ID [1] 0 0
MIS-FIH-2010-01
Universal Trial Number (UTN)
Trial acronym
DESSOLVE-I
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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).

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Angiographic In-Stent Late Lumen Loss - 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.
Timepoint [1] 0 0
8 months
Secondary outcome [1] 0 0
Percentage of Participants Experiencing Major Adverse Cardiac Events (MACE) - Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q-wave and non-Q-wave) and target vessel revascularization (TVR)
Timepoint [1] 0 0
240 days
Secondary outcome [2] 0 0
Device Success - Achievement of a final in-stent residual diameter stenosis of <50% (by QCA), using the assigned device only
Timepoint [2] 0 0
8 hours
Secondary outcome [3] 0 0
Lesion Success - Achievement of a final in-stent residual diameter stenosis of <50% (by QCA) using any percutaneous method
Timepoint [3] 0 0
8 hours
Secondary outcome [4] 0 0
Procedural Success - 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
Timepoint [4] 0 0
8 hours
Secondary outcome [5] 0 0
Total Mortality - Total mortality (cardiac and non-cardiac)
Timepoint [5] 0 0
240 days
Secondary outcome [6] 0 0
Total Myocardial Infarction (MI) - 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.
Timepoint [6] 0 0
240 days
Secondary outcome [7] 0 0
Clinically-driven Target Lesion Revascularization (TLR) Rates - 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.
Timepoint [7] 0 0
240 days
Secondary outcome [8] 0 0
Clinically-driven Target Vessel Revascularization (TVR) Rates - 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.
Timepoint [8] 0 0
240 days
Secondary outcome [9] 0 0
Target Vessel Failure (TVF) - 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
Timepoint [9] 0 0
240 days
Secondary outcome [10] 0 0
Target Lesion Failure (TLF) - 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
Timepoint [10] 0 0
240 days
Secondary outcome [11] 0 0
Stent Thrombosis - 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
Timepoint [11] 0 0
240 days
Secondary outcome [12] 0 0
Angiographic Evaluation: In-stent Binary Restenosis - Binary Restenosis is defined as =50% luminal narrowing at follow-up angiography.
Timepoint [12] 0 0
4 months, 6 months, 8 months
Secondary outcome [13] 0 0
Angiographic Evaluation: In-stent Binary Restenosis - Binary Restenosis is defined as =50% luminal narrowing at follow-up angiography.
Timepoint [13] 0 0
18 months
Secondary outcome [14] 0 0
Intravascular Ultrasound (IVUS) Evaluation: % Neointimal Volume Obstruction - % neointimal volume obstruction is defined as the neointimal volume divided by stent volume.
Timepoint [14] 0 0
8 months
Secondary outcome [15] 0 0
IVUS Evaluation: % Neointimal Volume Obstruction - % neointimal volume obstruction is defined as the neointimal volume divided by stent volume.
Timepoint [15] 0 0
18 months
Secondary outcome [16] 0 0
Optical Coherence Tomography (OCT) Evaluation: % Stent Strut Uncovered - % stent strut uncovered is defined as the ratio of uncovered struts to total struts in all cross-sections.
Timepoint [16] 0 0
8 months
Secondary outcome [17] 0 0
OCT Evaluation: % Stent Strut Uncovered - % stent strut uncovered is defined as the ratio of uncovered struts to total struts in all cross-sections.
Timepoint [17] 0 0
18 M

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.
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
St. Vincent's Hospital Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Aalst
Country [2] 0 0
Belgium
State/province [2] 0 0
Genk
Country [3] 0 0
New Zealand
State/province [3] 0 0
Auckland
Country [4] 0 0
New Zealand
State/province [4] 0 0
Aukland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Micell Technologies
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The DESSOLVE I clinical trial is to assess the safety and performance of the
sirolimus-eluting MiStent SES.
Trial website
https://clinicaltrials.gov/show/NCT01247428
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
William Wijns, MD
Address 0 0
Cardiovascular Center, Onze-Lieve-Vrouwziekenhuis Aalst (OLV Hospital)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries