Clinical Investigation of the MiStent Drug Eluting Stent (DES) in Coronary Artery Disease

Coronary Artery Disease Clinical Trial

— DESSOLVE-II  

Official title:

Clinical Investigation of a DES (MiStent™ System) With Sirolimus and a Bioabsorbable Polymer for the Treatment of Patients With De Novo Lesions in Native Coronary Arteries.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01294748
• Other study ID #: MIS-CEM-2010-02
• Status: Active, not recruiting
• Phase: Phase 2
• First received: February 10, 2011
• Last updated: April 7, 2015
• Start date: February 2011
• Est. completion date: August 2016

Study information

• Verified date: April 2015
• Source: Micell Technologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsNew Zealand: Health and Disability Ethics CommitteesAustralia: Department of Health and Ageing Therapeutic Goods AdministrationNetherlands: Dutch Health Care InspectorateFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Sweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Description:

The DESSOLVE II clinical trial is to assess the safety and performance of the sirolimus-eluting MiStent as compared to the Endeavor DES 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 184
• Est. completion date: August 2016
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

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 Exclusion Criteria:

• 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• 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).
• 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).

Locations

Country	Name	City	State
Belgium	Cardiovascular Center	Aalst
Belgium	Antwerp Hospital, ZNA Middelheim	Antwerp
Belgium	Brussels University Hospital	Brussels
Belgium	Ziekenhuis Oost-Limburg	Genk
Belgium	Virga Jesse Ziekenhuis	Hasselt
Belgium	KUL Cardiology Gasthuisberg	Leuven
France	Jacques Cartier Hospital	Massy
France	Claude Galien Hospital	Quincy
France	Clinique Pasteur	Toulouse
Netherlands	OLV	Amsterdam
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
Netherlands	TweeSteden Ziekenhuis	Tilburg
Netherlands	UMC Utrecht	Utrecht
Netherlands	Hospital Weezenlanden	Zwolle
New Zealand	Auckland City Hospital	Auckland
New Zealand	Mercy Angiography Unit	Auckland
New Zealand	Christchurch Hospital	Christchurch
New Zealand	Dunedin Hospital	Dunedin
New Zealand	Wellington Hospital	Wellington
Sweden	Sahlgrenska University Hospital	Goteborg
Sweden	Orebro University Hospital	Orebro
United Kingdom	Royal Sussex Hosp	Brighton
United Kingdom	Papworth Hospital	Cambridge
United Kingdom	Guy's & St. Thomas'	London
United Kingdom	Royal Brompton	London
United Kingdom	University Hospital South Manchester	Manchester
United Kingdom	Norfolk/Norwich UHosp	Norwich
United Kingdom	Southampton UHT	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
Micell Technologies

Countries where clinical trial is conducted

Belgium,  France,  Netherlands,  New Zealand,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	9 months	No
Primary	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.	9 months	Yes
Secondary	Device Success	Achievement of a final in-stent residual diameter stenosis of <50% (by QCA), using the assigned device only.	8 hours	Yes
Secondary	Lesion Success	Achievement of a final in-stent residual diameter stenosis of <50% (by QCA) using any percutaneous method.	8 hours	Yes
Secondary	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.	8 hours	Yes
Secondary	Total Mortality		9-months	Yes
Secondary	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.	9-months	Yes
Secondary	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.	9-months	Yes
Secondary	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	9-months	Yes
Secondary	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	9-months	Yes
Secondary	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	9-months	Yes