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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01294748




Registration number
NCT01294748
Ethics application status
Date submitted
10/02/2011
Date registered
11/02/2011
Date last updated
8/02/2017

Titles & IDs
Public title
Clinical Investigation of the MiStent Drug Eluting Stent (DES) in Coronary Artery Disease
Scientific title
Clinical Investigation of a DES (MiStentâ„¢ System) With Sirolimus and a Bioabsorbable Polymer for the Treatment of Patients With De Novo Lesions in Native Coronary Arteries.
Secondary ID [1] 0 0
MIS-CEM-2010-02
Universal Trial Number (UTN)
Trial acronym
DESSOLVE-II
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 DES
Treatment: Devices - Endeavor DES

Experimental: MiStent DES - The MiStent SES is a sirolimus-eluting absorbable polymer stent for coronary artery revascularization.

Active Comparator: Endeavor DES - The Endeavor DES is an everolimus-eluting durable polymer stent for coronary artery revascularization.


Treatment: Devices: MiStent DES
The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).

Treatment: Devices: Endeavor DES
The Endeavor is a device/drug combination comprised of two components; a stent and a drug product (everolimus within a durable polymer coating).

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

Outcomes
Primary outcome [1] 0 0
In-Stent Late Lumen Loss - Measured by the angiographic core laboratory as the difference between the post-procedure MLD in the treated segment (stented region) minus the MLD in the same region at follow-up
Timepoint [1] 0 0
9 months
Primary outcome [2] 0 0
Major Adverse Cardiac Events (MACE) - Defined as death, MI (Qwave and non-Q-wave) and TVR at 9 months post-procedure. Assessed on all patients with adequate follow-up at 270 days.
Timepoint [2] 0 0
9 months
Secondary outcome [1] 0 0
Device Success - Achievement of a final in-stent residual diameter stenosis of <50% (by QCA), using the assigned device only.
Timepoint [1] 0 0
8 hours
Secondary outcome [2] 0 0
Lesion Success - Achievement of a final in-stent residual diameter stenosis of <50% (by QCA) using any percutaneous method.
Timepoint [2] 0 0
8 hours
Secondary outcome [3] 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, MI or repeat revascularization of the target lesion pre-hospital discharge.
Timepoint [3] 0 0
8 hours
Secondary outcome [4] 0 0
Total Mortality
Timepoint [4] 0 0
9-months
Secondary outcome [5] 0 0
Total Myocardial Infarct (MI) - Q-wave MI (QWMI): requires one of the following criteria: 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 ULN elevation of CK levels; 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 (=3 times ULN) in the absence of new pathologic Q waves.
Peri-Procedural MI post PCI:Q or non-Q-wave MI, as defined above, prior to hospital discharge, or CK-MB elevation >3xULN within 48 hours post -PCI, with a normal CK-MB at baseline.
Timepoint [5] 0 0
9-months
Secondary outcome [6] 0 0
Clinically-driven Target Lesion Revascularization (TVR) - TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel (main branch or side branch). The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches, and the target lesion itself.
Timepoint [6] 0 0
9-months
Secondary outcome [7] 0 0
Target Vessel Failure (TVF) - Composite endpoint of cardiac death, target-vessel myocardial infarction (Q wave or non-Q wave), and clinically indicated target vessel revascularization
Timepoint [7] 0 0
9-months
Secondary outcome [8] 0 0
Target Lesion Failure (TLF) - Composite endpoint of cardiac death, target-lesion myocardial infarction (Q wave or non-Q wave), and clinically indicated target lesion revascularization
Timepoint [8] 0 0
9-months
Secondary outcome [9] 0 0
Stent Thrombosis (Definite/Probable) - 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 [9] 0 0
9-months

Eligibility
Key inclusion criteria
1. Age =18 and =85 years;

2. Stable/unstable angina pectoris (Class I-IV), documented ischemia/silent ischemia;

3. Planned single, de novo, types A, B1 or B2 coronary lesions;

4. Target lesion located in a native coronary artery;

5. Target lesion in vessel ranging from 2.5 to 3.5 mm amenable to treatment (coverage)
with a 30 mm long stent;

6. Target lesion with >50% diameter stenosis;

7. Recent Q-wave (>72 hours) or non-Q-wave myocardial infarction;

8. Patients eligible for PCI;

9. Candidate for CABG ;

10. A patient may have one additional critical non-target lesion.

11. Patient capable of providing informed consent and is willing to comply with all study
requirements.
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Female patients of childbearing potential who do not have a confirmed negative
pregnancy test at baseline and are not on some form of birth control;

2. Recent Q-wave MI < 72 hours prior to the index procedure.

3. Recent Q- or non-Q-wave MI with still elevated levels of cardiac markers (e.g. CK; and
CK-MB if the CK is elevated);

4. LVEF <30% (within the previous 6-months);

5. Patients in cardiogenic shock;

6. CVA or TIA within the past 6 months;

7. Active GI bleeding within past 3 months;

8. Any prior anaphylactic reaction to contrast agents;

9. Chemotherapy within 30-days before or after the index procedure;

10. Receiving oral or intravenous immunosuppressive therapy or has known life-limiting
immunosuppressive or autoimmune disease;

11. Renal dysfunction (creatinine > 2.0 mg/dL or 177 µmol/L);

12. Platelet count <100,000 cells/mm³ or >700,000 cells/mm³;

13. White blood cell count <3,000 cells/mm3;

14. Hepatic disease;

15. Heart transplant recipient;

16. Known contraindication to DAPT;

17. Known hypersensitivity to sirolimus, cobalt-chromium, or to medications such as
aspirin, heparin and Angiomax (bivalirudin), and all three of the following:
clopidogrel bisulfate (Plavix), ticlopidine (Ticlid), and Prasugrel (Effient);

18. Life expectancy less than 12 months;

19. Any major medical condition that may interfere with participation in this study;

20. Patient is currently participating in an investigational drug or another device study
and has not completed the follow-up to the primary endpoint, or the patient is
planning on participating prior to completing 12-months follow-up;

21. Target vessel has been treated within 10 mm proximal or distal to target lesion with
any type of PCI or within a year prior to index procedure;

22. 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;

23. Patient previously treated at any time with brachytherapy;

24. Planned coronary angioplasty or CABG in the first 9 months after the index procedure
or any other planned intervention within 30-days post index procedure;

25. Prior PCI of a non-target vessel must be at least 14 days prior to study enrollment;

26. The intent to direct stent the target lesion;

27. Angiographic

- In-stent restenotic target lesion;

- 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;

- Long target lesion not amenable to treatment with up to a 30 mm long stent;

- Left main critical disease (=50% DS);

- Target lesion is located in a surgical bypass graft;

- Total target vessel occlusion (TIMI flow grade 0-1);

- Target lesion ostial location;

- Target lesion at bifurcation involving side branch >2.5 mm or lateral branch that
also requires stenting;

- Calcified target lesion that anticipates unsuccessful/impracticable predilation;

- Target vessel with excessive tortuosity or proximal angulation;

- 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:

1. Located within the target vessel;

2. Located within a bypass graft ;

3. Left main location;

4. Chronic total occlusion

5. Involves a complex bifurcation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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?
The people receiving the treatment/s


Intervention assignment
Parallel
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 outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Aalst
Country [2] 0 0
Belgium
State/province [2] 0 0
Antwerp
Country [3] 0 0
Belgium
State/province [3] 0 0
Brussels
Country [4] 0 0
Belgium
State/province [4] 0 0
Genk
Country [5] 0 0
Belgium
State/province [5] 0 0
Hasselt
Country [6] 0 0
Belgium
State/province [6] 0 0
Leuven
Country [7] 0 0
France
State/province [7] 0 0
Massy
Country [8] 0 0
France
State/province [8] 0 0
Quincy
Country [9] 0 0
France
State/province [9] 0 0
Toulouse
Country [10] 0 0
Netherlands
State/province [10] 0 0
Amsterdam
Country [11] 0 0
Netherlands
State/province [11] 0 0
Nieuwegein
Country [12] 0 0
Netherlands
State/province [12] 0 0
Tilburg
Country [13] 0 0
Netherlands
State/province [13] 0 0
Utrecht
Country [14] 0 0
Netherlands
State/province [14] 0 0
Zwolle
Country [15] 0 0
New Zealand
State/province [15] 0 0
Auckland
Country [16] 0 0
New Zealand
State/province [16] 0 0
Christchurch
Country [17] 0 0
New Zealand
State/province [17] 0 0
Dunedin
Country [18] 0 0
New Zealand
State/province [18] 0 0
Wellington
Country [19] 0 0
Sweden
State/province [19] 0 0
Goteborg
Country [20] 0 0
Sweden
State/province [20] 0 0
Orebro
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Brighton
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Cambridge
Country [23] 0 0
United Kingdom
State/province [23] 0 0
London
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Manchester
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Norwich
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Southampton

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

Ethics approval
Ethics application status

Summary
Brief summary
The DESSOLVE II 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 in the
native coronary arteries.
Trial website
https://clinicaltrials.gov/show/NCT01294748
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

Summary results
Other publications