ClinicalTrials.gg
Not yet recruitingNCT03423511CRYSTALUpdated Sep 4, 2020

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

An interventional study of MiStent II coronary artery stent and Xience or Promus coronary artery stents in Coronary Artery Disease, sponsored by Micell Technologies. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-04.

Sponsored by Micell Technologies · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2023, 3 years 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
1,300
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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)

Read the 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.

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • MiStent
  • Coronary Artery Disease
  • Coronary Disease
  • Myocardial Ischemia
  • Heart Disease
  • Cardiovascular Diseases
  • Arteriosclerosis
  • Arterial Occlusive Diseases
  • Vascular Diseases
03

In context

Coronary Artery Disease

4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.

This study's planned enrollment of 1,300 is above the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Micell Technologies is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 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

Exclusion Criteria:

  1. Subject has clinical symptoms and/or (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 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 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 (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 (TIA) within the past 6 months
  16. Subject has severe symptomatic heart failure (i.e., (LVEF) \<30%))
  17. Subject is participating in another 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 who are sexually active must agree to use a reliable method of 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)
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
1,300 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DeviceMiStent II coronary artery stent

    Implantation of a coronary stent patient with stable and unstable coronary artery disease including non-ST-Elevated Myocardial Infarction

  • DeviceXience or Promus coronary artery stents

    Implantation of a coronary stent patient with stable and unstable coronary artery disease including non-ST-Elevated Myocardial Infarction

06

What researchers measure

Primary outcomes

  1. Target Lesion Failure (TLF)

    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.

    Time frame: through 12-month visit

Secondary outcomes

  1. Device success

    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.

    Time frame: Index Procedure

  2. Technical success

    Achieving a final diameter stenosis of \<30% (by visual estimation) in the target lesion using any combination of stents or devices allowed per protocol.

    Time frame: Index Procedure

  3. Procedural success

    Post-procedure diameter stenosis \<30% (by visual estimation) in all target lesions and the absence of in-hospital MI, TVR, or cardiac death.

    Time frame: Index Procedure

  4. Composite Endpoint POCE

    POCE defined as all-cause death, any MI, or any revascularization

    Time frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up

  5. Composite Endpoint MACE

    MACE defined as all-cause death, any MI, or any TVR

    Time frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up

  6. Composite Endpoint TVF

    TVF defined as cardiac death, TV MI, or clinically indicated TVR

    Time frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up

  7. Composite Endpoint TLF

    TLF defined as cardiac death, TV MI or Ischemia driven TLR

    Time frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up

  8. Mortality

    Mortality including All death, Cardiac death, and Non-cardiac death (vascular and non-cardiovascular)

    Time frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up

  9. Myocardial Infarction

    Myocardial Infarction including All MI, TV-MI, and Non-TV-MI

    Time frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up

  10. Revascularization

    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

    Time frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up

  11. Stent thrombosis rates

    Stent thrombosis rates according to ARC classification: ST - Early (Acute, Sub-acute), Late, Very Late; ST - Definite, Probable, Possible

    Time frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up

  12. Serious Adverse Events (SAEs)

    * All SAEs through 12 months' post-index procedure * All device related SAEs from 12 months through 5 years' post-index procedure

    Time frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03423511
Lead sponsor
Micell Technologies
Collaborators
Baim Institute for Clinical Research, North American Science Associates Inc., Yale Cardiovascular Research Group
Responsible party
Sponsor
First posted
Feb 6, 2018
Start date
Dec 31, 2021 (estimated)
Primary completion
Jun 1, 2023 (estimated)
Completion
Jun 1, 2027 (estimated)
Last update
Sep 4, 2020

Study contacts

Jeffrey Mifek
Contact
jmifek@micell.com
919-313-2102
Christopher DiMatteo
Contact
cdimatteo@namsa.com
480-765-8584
Laura Mauri, MD, MSc
study chair · Brigham and Women's Hospial
Dean Kereiakes, MD
principal investigator · The Christ Hospital
David Kandzari, MD
principal investigator · Piedmont Heart Institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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