First-In-Human Trial of the MiStent Drug-Eluting Stent (DES) in Coronary Artery Disease (DESSOLVE-I)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Micell Technologies
ClinicalTrials.gov Identifier:
NCT01247428
First received: November 18, 2010
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

The DESSOLVE I clinical trial is to assess the safety and performance of the sirolimus-eluting MiStent SES.


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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Micell Technologies:

Primary Outcome Measures:
  • Angiographic In-Stent Late Lumen Loss [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percentage of Participants Experiencing Major Adverse Cardiac Events (MACE) [ Time Frame: 240 days ] [ Designated as safety issue: Yes ]
    Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q-wave and non-Q-wave) and target vessel revascularization (TVR)

  • 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, Myocardial infarction (MI) or repeat revascularization of the target lesion pre-hospital discharge

  • Total Mortality [ Time Frame: 240 days ] [ Designated as safety issue: Yes ]
    Total mortality (cardiac and non-cardiac)

  • Total Myocardial Infarction (MI) [ Time Frame: 240 days ] [ Designated as safety issue: Yes ]
    1. 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.
    2. 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.

  • Clinically-driven Target Lesion Revascularization (TLR) Rates [ Time Frame: 240 days ] [ Designated as safety issue: Yes ]

    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:

    1. A positive history of recurrent angina pectoris, presumably related to the target vessel;
    2. Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
    3. Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve);
    4. A target lesion revascularization (TLR) with a diameter stenosis ≥ 70% even in the absence of the above-mentioned ischemic signs or symptoms.

  • Clinically-driven Target Vessel Revascularization (TVR) Rates [ Time Frame: 240 days ] [ Designated as safety issue: Yes ]

    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:

    1. A positive history of recurrent angina pectoris, presumably related to the target vessel;
    2. Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
    3. Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve);
    4. A target vessel revascularization (TVR) with a diameter stenosis ≥ 70% even in the absence of the above-mentioned ischemic signs or symptoms.

  • Target Vessel Failure (TVF) [ Time Frame: 240 days ] [ Designated as safety issue: Yes ]

    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

  • Target Lesion Failure (TLF) [ Time Frame: 240 days ] [ Designated as safety issue: Yes ]

    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

  • Stent Thrombosis [ Time Frame: 240 days ] [ 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

  • Angiographic Evaluation: In-stent Binary Restenosis [ Time Frame: 4 months, 6 months, 8 months ] [ Designated as safety issue: Yes ]
    Binary Restenosis is defined as ≥50% luminal narrowing at follow-up angiography.

  • Angiographic Evaluation: In-stent Binary Restenosis [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Binary Restenosis is defined as ≥50% luminal narrowing at follow-up angiography.

  • Intravascular Ultrasound (IVUS) Evaluation: % Neointimal Volume Obstruction [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
    % neointimal volume obstruction is defined as the neointimal volume divided by stent volume.

  • IVUS Evaluation: % Neointimal Volume Obstruction [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    % neointimal volume obstruction is defined as the neointimal volume divided by stent volume.

  • Optical Coherence Tomography (OCT) Evaluation: % Stent Strut Uncovered [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
    % stent strut uncovered is defined as the ratio of uncovered struts to total struts in all cross-sections.

  • OCT Evaluation: % Stent Strut Uncovered [ Time Frame: 18 M ] [ Designated as safety issue: Yes ]
    % stent strut uncovered is defined as the ratio of uncovered struts to total struts in all cross-sections.


Enrollment: 30
Study Start Date: November 2010
Estimated Study Completion Date: January 2016
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
Device: 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).

Detailed Description:

The DESSOLVE I 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 < 20 mm in length in the native coronary arteries with reference vessel diameters between 2.5 mm and 3.5 mm.

  Eligibility

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

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.

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 Exclusion Criteria: 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.
  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: NCT01247428

Locations
Australia
St. Vincent's Hospital Melbourne
Melbourne, Australia
Belgium
Onze-Lieve-Vrouwziekenhuis Aalst (OLV Hospital)
Aalst, Belgium
Ziekenhuis Oost-Limburg
Genk, Belgium
New Zealand
Auckland City Hospital
Auckland, New Zealand, 1032
Mercy Angiography Unit - Mercy Hospital
Aukland, New Zealand, 1032
Sponsors and Collaborators
Micell Technologies
Investigators
Principal Investigator: William Wijns, MD Cardiovascular Center, Onze-Lieve-Vrouwziekenhuis Aalst (OLV Hospital)
Principal Investigator: John Ormiston, MD Mercy Angiography Unit
  More Information

Publications:
Responsible Party: Micell Technologies
ClinicalTrials.gov Identifier: NCT01247428     History of Changes
Other Study ID Numbers: MIS-FIH-2010-01
Study First Received: November 18, 2010
Results First Received: December 19, 2013
Last Updated: June 10, 2014
Health Authority: New Zealand: Health and Disability Ethics Committees

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

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

ClinicalTrials.gov processed this record on October 30, 2014