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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Micell Technologies
ClinicalTrials.gov Identifier:
NCT01294748
First received: February 10, 2011
Last updated: February 6, 2014
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Device: MiStent DES
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Micell Technologies:

Primary Outcome Measures:
  • In-Stent Late Lumen Loss [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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

  • Major Adverse Cardiac Events (MACE) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Device Success [ Time Frame: 8 hours ] [ Designated as safety issue: Yes ]
    Achievement of a final in-stent residual diameter stenosis of <50% (by QCA), using the assigned device only.

  • Lesion Success [ Time Frame: 8 hours ] [ Designated as safety issue: Yes ]
    Achievement of a final in-stent residual diameter stenosis of <50% (by QCA) using any percutaneous method.

  • Procedural Success [ Time Frame: 8 hours ] [ Designated as safety issue: Yes ]
    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.

  • Total Mortality [ Time Frame: 9-months ] [ Designated as safety issue: Yes ]
  • Total Myocardial Infarct (MI) [ Time Frame: 9-months ] [ Designated as safety issue: Yes ]
    1. 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.
    2. 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.
    3. 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.

  • Clinically-driven Target Lesion Revascularization (TVR) [ Time Frame: 9-months ] [ Designated as safety issue: Yes ]
    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.

  • Target Vessel Failure (TVF) [ Time Frame: 9-months ] [ Designated as safety issue: Yes ]
    Composite endpoint of cardiac death, target-vessel myocardial infarction (Q wave or non-Q wave), and clinically indicated target vessel revascularization

  • Target Lesion Failure (TLF) [ Time Frame: 9-months ] [ Designated as safety issue: Yes ]
    Composite endpoint of cardiac death, target-lesion myocardial infarction (Q wave or non-Q wave), and clinically indicated target lesion revascularization

  • Stent Thrombosis (Definite/Probable) [ Time Frame: 9-months ] [ Designated as safety issue: Yes ]
    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


Enrollment: 184
Study Start Date: February 2011
Estimated Study Completion Date: August 2016
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MiStent DES 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).
Active Comparator: Endeavor DES 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).

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female patients of age ≥18 years and ≤85 years;
  2. Documented stable or unstable angina pectoris (Class I, II, III or IV), documented ischemia, or documented silent ischemia;
  3. Planned single, de novo, types A, B1 or B2 coronary lesions (according to the ACC/AHA classification);
  4. Target lesion located in a native coronary artery;
  5. Target lesion in vessel with diameter ranging from 2.5 to 3.5 mm amenable to treatment (coverage) with a maximum 30 mm long stent;
  6. Target lesion with >50% diameter stenosis;
  7. If the patient has had a recent Q-wave (>72 hours) or non-Q-wave myocardial infarction, the CK, CK-MB levels should have returned to normal(<ULN).
  8. Patients who are eligible for percutaneous coronary intervention (PCI);
  9. Acceptable candidate for myocardial revascularization surgery (coronary artery bypass graft surgery);
  10. A patient may have one additional critical non-target lesion. The target lesion is the only lesion that must meet the study inclusion requirements. The non-target lesion may be treated at the time of the index procedure but must be successfully treated without complications before the target lesion. The non-target lesion will not be considered to be part of the study and does not require the follow-up evaluations defined in the protocol. If more than one lesion meets the inclusion criteria, only one lesion/vessel chosen by the Investigator should be treated with the study stent; the other lesion(s) should be treated outside the study with approved devices;
  11. The patient is judged to be capable of providing involuntary informed consent and has been fully informed of the nature of the study, is willing to comply with all study requirements and will provide written informed consent as approved by the Ethics Committee of the respective clinical site.
  12. The patient is affiliated with a social security system (if required by individual country regulations).

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 myocardial infarction occurred within 72 hours prior to the index procedure.
  3. Recent Q-wave or non-Q-wave myocardial infarction with still elevated levels of cardiac markers (e.g. CK; and CK-MB if the CK is elevated);
  4. Left ventricular ejection fraction <30% (within the previous 6-months);
  5. Patients in cardiogenic shock;
  6. Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months;
  7. Active GI bleeding within past three months;
  8. Any prior true anaphylactic reaction to contrast agents;
  9. Patient is receiving or scheduled to receive chemotherapy within 30-days before or after the index procedure;
  10. Patient is receiving oral or intravenous immunosuppressive therapy or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus);
  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. Suspected or documented hepatic disease (including laboratorial evidence of hepatitis);
  15. Heart transplant recipient;
  16. Known contraindication to dual antiplatelet therapy (DAPT);
  17. Known hypersensitivity to sirolimus (or its structurally related compounds), 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. Concurrent medical condition with a life expectancy of less than 12 months;
  19. Any major medical condition that, in the Investigator's opinion, may interfere with the optimal participation of the patient 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 in an investigational drug or another device study during the course of the present investigation prior to completing 12-months follow-up;
  21. Target vessel has been treated within 10 mm proximal or distal to target lesion (by visual estimate) with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) 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 coronary intravascular brachytherapy;
  24. Planned coronary angioplasty (with or without stenting) 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: To be assessed at the time of the index procedure catheterization prior to randomization and stent placement using visual estimate or online QCA, as appropriate;

    • In-stent restenotic target lesion;
    • In-stent restenotic target lesion;
    • More than one lesion requiring treatment in the target vessel (i.e. another lesion with >50% diameter stenosis (DS) proximal or distal to the target lesion);
    • Target vessel diameter <2.5 mm or >3.5 mm;
    • Long target lesion not amenable to treatment (coverage) 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 with ostial location (within 5 mm of ostium by visual assessment);
    • Target lesion at a bifurcation involving a side branch >2.5 mm or a lateral branch that also requires stenting;
    • Calcified target lesion that anticipates unsuccessful/impracticable predilation;
    • Target vessel with 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:

      1. Located within the target vessel;
      2. Located within a bypass graft (venous or arterial);
      3. Left main location;
      4. Chronic total occlusion
      5. Involves a complex bifurcation (e.g., bifurcations requiring treatment with more than one stent).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01294748

Locations
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, Belgium
France
Jacques Cartier Hospital
Massy, France
Claude Galien Hospital
Quincy, France
Clinique Pasteur
Toulouse, France
Netherlands
OLV
Amsterdam, Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
TweeSteden Ziekenhuis
Tilburg, Netherlands
UMC Utrecht
Utrecht, Netherlands
Hospital Weezenlanden
Zwolle, Netherlands
New Zealand
Mercy Angiography Unit
Auckland, New Zealand
Auckland City Hospital
Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand
Dunedin Hospital
Dunedin, New Zealand
Wellington Hospital
Wellington, New Zealand
Sweden
Sahlgrenska University Hospital
Goteborg, Sweden
Orebro University Hospital
Orebro, Sweden
United Kingdom
Royal Sussex Hosp
Brighton, United Kingdom
Papworth Hospital
Cambridge, United Kingdom
Royal Brompton
London, United Kingdom
Guy's & St. Thomas'
London, United Kingdom
University Hospital South Manchester
Manchester, United Kingdom
Norfolk/Norwich UHosp
Norwich, United Kingdom
Southampton UHT
Southampton, United Kingdom
Sponsors and Collaborators
Micell Technologies
Investigators
Principal Investigator: William Wijns, MD Cardiovascular Center, Onze-Lieve-Vrouwziekenhuis Aalst (OLV Hospital)
  More Information

No publications provided

Responsible Party: Micell Technologies
ClinicalTrials.gov Identifier: NCT01294748     History of Changes
Other Study ID Numbers: MIS-CEM-2010-02
Study First Received: February 10, 2011
Results First Received: February 6, 2014
Last Updated: February 6, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
New Zealand: Health and Disability Ethics Committees
Australia: Department of Health and Ageing Therapeutic Goods Administration
Netherlands: Dutch Health Care Inspectorate
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Micell Technologies:
Coronary Artery Disease
Drug-eluting Stent
Sirolimus

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 22, 2014