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Trial to Demonstrate the Safety and Effectiveness of the MiStent II for the Revascularization of Coronary Arteries. (CRYSTAL)

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ClinicalTrials.gov Identifier: NCT03423511
Recruitment Status : Not yet recruiting
First Posted : February 6, 2018
Last Update Posted : August 15, 2018
Sponsor:
Collaborators:
Baim Institute for Clinical Research
North American Science Associates Inc.
Yale Cardiovascular Research Group
Information provided by (Responsible Party):
Micell Technologies

Brief Summary:
To compare MiStent to either the Xience or Promus stents.with the primary objective being to assess the safety and efficacy of the MiStent in a patient population requiring revascularization of de novo obstructive lesions of coronary arteries in patients with stable and unstable coronary artery disease (CAD) including non ST-Elevation Myocardial Infarction (NSTEMI)

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: MiStent II coronary artery stent Device: Xience or Promus coronary artery stents Not Applicable

Detailed Description:

The CRYSTAL study is a prospective, multi-center, randomized (1:1), single-blinded and controlled, investigational device exemption trial to test the non-inferiority of MiStent to commercially available "everolimus" drug eluting stents (Xience and Promus stents).

Patients with coronary artery disease (CAD) that qualify for percutaneous coronary intervention (PCI) with stenting will be screened per the protocol inclusion and exclusion criteria.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: MiStent group vs. the Xience/Promus group.
Masking: Single (Participant)
Masking Description: This is a single-blind trial, such that the patient or patient's family will NOT be told which stent they have received.
Primary Purpose: Treatment
Official Title: CRYSTAL Study: A Multi-Center, Randomized, Controlled Trial to Demonstrate the Safety and Effectiveness of the MiStent II for the Revascularization of Coronary Arteries.
Estimated Study Start Date : March 31, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MiStent II Coronary Artery Stent
Implantation of a coronary artery stent in an all-comers population, including patients with symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes, who qualify for percutaneous coronary interventions
Device: MiStent II coronary artery stent
Implantation of a coronary stent patient with stable and unstable coronary artery disease including non-ST-Elevated Myocardial Infarction

Active Comparator: Xience or Promus Coronary Artery Stents
Implantation of a coronary artery stent in an all-comers population, including patients with symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes, who qualify for percutaneous coronary interventions
Device: Xience or Promus coronary artery stents
Implantation of a coronary stent patient with stable and unstable coronary artery disease including non-ST-Elevated Myocardial Infarction




Primary Outcome Measures :
  1. Target Lesion Failure (TLF) [ Time Frame: through 12-month visit ]

    Any occurrence of Target Lesion Failure (TLF)

    TLF is defined as:

    Cardiac death, or Target vessel myocardial infarction (TV-MI, Q-wave and non Q-wave), or Ischemia driven target lesion revascularization.



Secondary Outcome Measures :
  1. Device success [ Time Frame: Index Procedure ]
    Successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization with post procedure diameter stenosis of < 30% (by visual estimation) in the Target Lesion.

  2. Technical success [ Time Frame: Index Procedure ]
    Achieving a final diameter stenosis of <30% (by visual estimation) in the target lesion using any combination of stents or devices allowed per protocol.

  3. Procedural success [ Time Frame: Index Procedure ]
    Post-procedure diameter stenosis <30% (by visual estimation) in all target lesions and the absence of in-hospital MI, TVR, or cardiac death.

  4. Composite Endpoint POCE [ Time Frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up ]
    POCE defined as all-cause death, any MI, or any revascularization

  5. Composite Endpoint MACE [ Time Frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up ]
    MACE defined as all-cause death, any MI, or any TVR

  6. Composite Endpoint TVF [ Time Frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up ]
    TVF defined as cardiac death, TV MI, or clinically indicated TVR

  7. Composite Endpoint TLF [ Time Frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up ]
    TLF defined as cardiac death, TV MI or Ischemia driven TLR

  8. Mortality [ Time Frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up ]
    Mortality including All death, Cardiac death, and Non-cardiac death (vascular and non-cardiovascular)

  9. Myocardial Infarction [ Time Frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up ]
    Myocardial Infarction including All MI, TV-MI, and Non-TV-MI

  10. Revascularization [ Time Frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up ]
    Revascularization including Target Lesion revascularization (TLR) (any, clinically- indicated TLR, non-clinically indicated TLR), Target Vessel revascularization (TVR) (any, clinically- indicated TVR, non-clinically indicated TVR), Non-TV revascularization, and Any revascularization

  11. Stent thrombosis rates [ Time Frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up ]
    Stent thrombosis rates according to ARC classification: ST - Early (Acute, Sub-acute), Late, Very Late; ST - Definite, Probable, Possible

  12. Serious Adverse Events (SAEs) [ Time Frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up ]
    • All SAEs through 12 months' post-index procedure
    • All device related SAEs from 12 months through 5 years' post-index procedure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject must be ≥ 18 years of age
  2. Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed
  3. Subject is eligible for percutaneous coronary intervention (PCI)
  4. Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia
  5. Subject is an acceptable candidate for coronary artery bypass grafting (CABG)
  6. Subject is willing to comply with all protocol-required follow-up evaluation

    Angiographic Inclusion Criteria (visual estimate):

  7. Target lesion(s) must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥2.50 mm and ≤3.50 mm
  8. Target lesion(s) must be able to be treated with a single stent and the target lesion length must be ≤27 mm (by visual estimate).

    NOTE: Only lesion lengths that have both the control and comparable investigational stent lengths available at the same time are eligible for enrollment.

  9. Target lesion(s) must have visually estimated stenosis ≥50% and <100% with thrombolysis in Myocardial Infarction (TIMI) flow >1 and one of the following:

    1. Stenosis ≥70% or;
    2. Abnormal fractional flow reserve (FFR) defined as <0.80 or;
    3. Abnormal stress or imaging stress test or;
    4. Elevated biomarkers prior to the procedure
  10. Coronary anatomy is likely to allow delivery of a study device to the target lesions(s)
  11. The first lesion treated must be successfully predilated/pretreated

Exclusion Criteria:

  1. Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation MI (STEMI)
  2. Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina
  3. Subject has received an organ transplant or is on a waiting list for an organ transplant
  4. Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure
  5. Planned PCI (including staged procedures) or CABG after the index procedure
  6. Subject previously treated at any time with intravascular brachytherapy in the target vessel(s)
  7. Subject has a known allergy to contrast (that cannot be adequately premedicated) and/or the trial stent system or protocol-required concomitant medications (e.g., Cobalt-chromium alloy, stainless steel, everolimus or structurally related compounds, polymer or individual components, all P2Y12 inhibitors, or aspirin)
  8. Subject has one of the following (as assessed prior to the index procedure):

    1. Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life expectancy of less than 24 months
    2. Current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.)
    3. Planned procedure that may cause non-compliance with the protocol or confound data interpretation
  9. Subject is receiving chronic (≥72 hours) anticoagulation therapy (i.e., heparin, coumadin, or other anticoagulation therapy) for indications other than acute coronary syndrome
  10. Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3
  11. Subject has a white blood cell (WBC) count < 3,000 cells/mm3
  12. Subject has documented or suspected liver disease, including laboratory evidence of hepatitis
  13. Subject is on dialysis or has baseline glomerular filtration rate (GFR) of <30 ml/min
  14. Subject has a history of bleeding diathesis, active peptic ulcer or gastrointestinal (GI) bleed, or coagulopathy or will refuse blood transfusions
  15. Subject has had a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months
  16. Subject has severe symptomatic heart failure (i.e., Left Ventricular Ejection Fraction (LVEF) <30%))
  17. Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint
  18. Subject intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure
  19. Subject with known intention to procreate within 12 months after the index procedure (women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure)
  20. Subject is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential)

    Angiographic Exclusion Criteria (visual estimate):

  21. Planned treatment of a single lesion with more than 1 stent
  22. Planned treatment of more than 3 lesions
  23. Planned treatment of lesions in more than 2 major epicardial vessels
  24. Planned treatment of more than 2 lesions in a single major epicardial vessel
  25. Subject has 2 target lesions in the same vessel that are separated by less than 15 mm (by visual estimate)
  26. Target lesion(s) is located in the left main or unprotected left
  27. Target lesion(s) is located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCx) coronary artery by visual estimate
  28. Target lesion(s) is located within a saphenous vein graft or an arterial graft
  29. Target lesion(s) will be accessed via a saphenous vein graft or arterial graft
  30. Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing
  31. Target lesion(s) treated during the index procedure that involves a complex bifurcation (e.g., bifurcation lesion requiring treatment with more than 1 stent)
  32. Target lesion(s) is restenotic from a previous stent implantation or study stent would overlap with a previous stent
  33. Subject has been treated with any type of PCI (i.e., balloon angioplasty, stent, cutting balloon atherectomy) within 24 hours prior to the index procedure
  34. Significant thrombus, present in the target vessel (by visual estimate)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03423511


Contacts
Contact: Jeffrey Mifek 919-313-2102 jmifek@micell.com
Contact: Christopher DiMatteo 480-765-8584 cdimatteo@namsa.com

Sponsors and Collaborators
Micell Technologies
Baim Institute for Clinical Research
North American Science Associates Inc.
Yale Cardiovascular Research Group
Investigators
Study Chair: Laura Mauri, MD, MSc Brigham and Women's Hospial
Principal Investigator: Dean Kereiakes, MD The Christ Hospital
Principal Investigator: David Kandzari, MD Piedmont Heart Institute

Responsible Party: Micell Technologies
ClinicalTrials.gov Identifier: NCT03423511     History of Changes
Other Study ID Numbers: MIS-US-2017-01
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Micell Technologies:
MiStent
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases