Clinical trial NCT01294748: Clinical Investigation of the MiStent Drug Eluting Stent (DES) in Coronary Artery Disease
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.
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: 2011-02-11
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: In-Stent Late Lumen Loss
timeFrame: 9 months
measure: Major Adverse Cardiac Events (MACE)
timeFrame: 9 months
Secondary outcomes:
measure: Device Success
timeFrame: 8 hours
measure: Lesion Success
timeFrame: 8 hours
measure: Procedural Success
timeFrame: 8 hours
measure: Total Mortality
timeFrame: 9-months
measure: Total Myocardial Infarct (MI)
timeFrame: 9-months
measure: Clinically-driven Target Lesion Revascularization (TVR)
timeFrame: 9-months
measure: Target Vessel Failure (TVF)
timeFrame: 9-months
measure: Target Lesion Failure (TLF)
timeFrame: 9-months
measure: Stent Thrombosis (Definite/Probable)
timeFrame: 9-months
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Cardiovascular Center
city: Antwerp
country: Belgium
facility: Antwerp Hospital, ZNA Middelheim
city: Brussels
country: Belgium
facility: Brussels University Hospital
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Hasselt
country: Belgium
facility: Virga Jesse Ziekenhuis
city: Leuven
country: Belgium
facility: KUL Cardiology Gasthuisberg
city: Massy
country: France
facility: Jacques Cartier Hospital
city: Quincy
country: France
facility: Claude Galien Hospital
city: Toulouse
country: France
facility: Clinique Pasteur
city: Amsterdam
country: Netherlands
facility: OLV
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Tilburg
country: Netherlands
facility: TweeSteden Ziekenhuis
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Zwolle
country: Netherlands
facility: Hospital Weezenlanden
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Auckland
country: New Zealand
facility: Mercy Angiography Unit
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Dunedin
country: New Zealand
facility: Dunedin Hospital
city: Wellington
country: New Zealand
facility: Wellington Hospital
city: Goteborg
country: Sweden
facility: Sahlgrenska University Hospital
city: Orebro
country: Sweden
facility: Orebro University Hospital
city: Brighton
country: United Kingdom
facility: Royal Sussex Hosp
city: Cambridge
country: United Kingdom
facility: Papworth Hospital
city: London
country: United Kingdom
facility: Guy's & St. Thomas'
city: London
country: United Kingdom
facility: Royal Brompton
city: Manchester
country: United Kingdom
facility: University Hospital South Manchester
city: Norwich
country: United Kingdom
facility: Norfolk/Norwich UHosp
city: Southampton
country: United Kingdom
facility: Southampton UHT
Study officials:
affiliation: Cardiovascular Center, Onze-Lieve-Vrouwziekenhuis Aalst (OLV Hospital)
name: William Wijns, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rusinaru D, Vrolix M, Verheye S, Chowdhary S, Schoors D, Di Mario C, Desmet W, Donohoe DJ, Ormiston JA, Knape C, Bezerra H, Lansky A, Wijns W; DESSOLVE II Investigators. Bioabsorbable polymer-coated sirolimus-eluting stent implantation preserves coronary vasomotion: A DESSOLVE II trial sub-study. Catheter Cardiovasc Interv. 2015 Dec 1;86(7):1141-50. doi: 10.1002/ccd.25610. Epub 2015 Sep 22.
citation: Wijns W, Vrolix M, Verheye S, Schoors D, Slagboom T, Gosselink M, Benit E, Donohoe D, Knape C, Attizzani GF, Lansky AJ, Ormiston J; DESSOLVE II Investigators. Randomised study of a bioabsorbable polymer-coated sirolimus-eluting stent: results of the DESSOLVE II trial. EuroIntervention. 2015 Apr;10(12):1383-90. doi: 10.4244/EIJY14M05_03.