Coronary Artery DiseaseCRYSTALNCT03423511

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

A study testing MiStent II coronary artery stent and Xience or Promus coronary artery stents in people with Coronary Artery Disease, run by Micell Technologies.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Artery Disease
What is being tested?: MiStent II coronary artery stent and Xience or Promus coronary artery stents
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,300 participants
Where: No sites listed yet
Study dates: 31 Dec 2021to 1 Jun 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject must be ≥ 18 years of age
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
Subject is eligible for percutaneous coronary intervention (PCI)
Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia
Subject is an acceptable candidate for coronary artery bypass grafting (CABG)
Subject is willing to comply with all protocol-required follow-up evaluation

Show all 17Show fewer

Angiographic Inclusion Criteria (visual estimate):
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
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.
Target lesion(s) must have visually estimated stenosis ≥50% and <100% with thrombolysis in Myocardial Infarction (TIMI) flow >1 and one of the following:
Stenosis ≥70% or;
Abnormal fractional flow reserve (FFR) defined as <0.80 or;
Abnormal stress or imaging stress test or;
Elevated biomarkers prior to the procedure
Coronary anatomy is likely to allow delivery of a study device to the target lesions(s)
The first lesion treated must be successfully predilated/pretreated

Who cannot join

Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation MI (STEMI)
Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina
Subject has received an organ transplant or is on a waiting list for an organ transplant
Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure
Planned PCI (including staged procedures) or CABG after the index procedure
Subject previously treated at any time with intravascular brachytherapy in the target vessel(s)

Show all 38Show fewer

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)
Subject has one of the following (as assessed prior to the index procedure):
Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life expectancy of less than 24 months
Current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.)
Planned procedure that may cause non-compliance with the protocol or confound data interpretation
Subject is receiving chronic (≥72 hours) anticoagulation therapy (i.e., heparin, coumadin, or other anticoagulation therapy) for indications other than acute coronary syndrome
Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3
Subject has a white blood cell (WBC) count < 3,000 cells/mm3
Subject has documented or suspected liver disease, including laboratory evidence of hepatitis
Subject is on dialysis or has baseline glomerular filtration rate (GFR) of <30 ml/min
Subject has a history of bleeding diathesis, active peptic ulcer or gastrointestinal (GI) bleed, or coagulopathy or will refuse blood transfusions
Subject has had a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months
Subject has severe symptomatic heart failure (i.e., Left Ventricular Ejection Fraction (LVEF) <30%))
Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint
Subject intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure
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)
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):
Planned treatment of a single lesion with more than 1 stent
Planned treatment of more than 3 lesions
Planned treatment of lesions in more than 2 major epicardial vessels
Planned treatment of more than 2 lesions in a single major epicardial vessel
Subject has 2 target lesions in the same vessel that are separated by less than 15 mm (by visual estimate)
Target lesion(s) is located in the left main or unprotected left
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
Target lesion(s) is located within a saphenous vein graft or an arterial graft
Target lesion(s) will be accessed via a saphenous vein graft or arterial graft
Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing
Target lesion(s) treated during the index procedure that involves a complex bifurcation (e.g., bifurcation lesion requiring treatment with more than 1 stent)
Target lesion(s) is restenotic from a previous stent implantation or study stent would overlap with a previous stent
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
Significant thrombus, present in the target vessel (by visual estimate)

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Jeffrey Mifek contact

919-313-2102

jmifek@micell.com

Christopher DiMatteo contact

480-765-8584

cdimatteo@namsa.com

About this study

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.

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.

Conditions: Coronary Artery Disease
Being tested: MiStent II coronary artery stent, Xience or Promus coronary artery stents
Keywords: MiStent, Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Heart Disease, Cardiovascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Vascular Diseases
Medical subject headings: Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MiStent II coronary artery stentDevice
Implantation of a coronary stent patient with stable and unstable coronary artery disease including non-ST-Elevated Myocardial Infarction
Xience or Promus coronary artery stentsDevice
Implantation of a coronary stent patient with stable and unstable coronary artery disease including non-ST-Elevated Myocardial Infarction

Study groups in NCT03423511
Study group	Role	What they receive
MiStent II Coronary Artery Stent	Experimental	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 Receives: Device: MiStent II coronary artery stent
Xience or Promus Coronary Artery Stents	Active comparator	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 Receives: Device: Xience or Promus coronary artery stents

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: through 12-month visit

Secondary outcomes (12)

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.
Measured: Index Procedure
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.
Measured: Index Procedure
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.
Measured: Index Procedure
Composite Endpoint POCE
POCE defined as all-cause death, any MI, or any revascularization
Measured: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up
Composite Endpoint MACE
MACE defined as all-cause death, any MI, or any TVR
Measured: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up
Composite Endpoint TVF
TVF defined as cardiac death, TV MI, or clinically indicated TVR
Measured: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up
Composite Endpoint TLF
TLF defined as cardiac death, TV MI or Ischemia driven TLR
Measured: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up
Mortality
Mortality including All death, Cardiac death, and Non-cardiac death (vascular and non-cardiovascular)
Measured: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up
Myocardial Infarction
Myocardial Infarction including All MI, TV-MI, and Non-TV-MI
Measured: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up
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
Measured: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up
Stent thrombosis rates
Stent thrombosis rates according to ARC classification: ST - Early (Acute, Sub-acute), Late, Very Late; ST - Definite, Probable, Possible
Measured: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up
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
Measured: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Dec 20211 Jun 2027

First posted6 Feb 2018
Study start31 Dec 2021 (estimated)
Primary completion1 Jun 2023 (estimated)
Study completion1 Jun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: MiStent group vs. the Xience/Promus group.
Masking: Single blind
Who is masked: Participant
Enrolment: 1,300 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03423511
Sponsor's protocol ID: MIS-US-2017-01
Acronym: CRYSTAL
Status last verified: Sep 2020
First submitted: 23 Jan 2018
Last updated: 4 Sep 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT03423511
Acronym / sponsor ID: CRYSTAL / MIS-US-2017-01
Conditions: Coronary Artery Disease
Keywords: MiStent, Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Heart Disease, Cardiovascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 1,300 participants (estimated)
Lead sponsor: Micell TechnologiesIndustry (pharma, biotech, devices)
Collaborators: Baim Institute for Clinical Research, North American Science Associates Inc., Yale Cardiovascular Research Group
Study start: 31 Dec 2021 (estimated)
Primary completion: 1 Jun 2023 (estimated)
Study completion: 1 Jun 2027 (estimated)
First posted: 6 Feb 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: MiStent group vs. the Xience/Promus group.

Arm	Type	Receives
MiStent II Coronary Artery Stent	Experimental	Device: MiStent II coronary artery stentImplantation 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
Xience or Promus Coronary Artery Stents	Active comparator	Device: Xience or Promus coronary artery stentsImplantation 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

Subject must be ≥ 18 years of age
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
Subject is eligible for percutaneous coronary intervention (PCI)
Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia
Subject is an acceptable candidate for coronary artery bypass grafting (CABG)

Key exclusion criteria (38 listed)

Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation MI (STEMI)
Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina
Subject has received an organ transplant or is on a waiting list for an organ transplant
Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure
Planned PCI (including staged procedures) or CABG after the index procedure

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MiStent II coronary artery stentImplantation of a coronary stent patient with stable and unstable coronary artery disease including non-ST-Elevated Myocardial Infarction	Device	MiStent II Coronary Artery Stent
Xience or Promus coronary artery stentsImplantation of a coronary stent patient with stable and unstable coronary artery disease including non-ST-Elevated Myocardial Infarction	Device	Xience or Promus Coronary Artery Stents

Primary outcome

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.

12 secondary outcomes

Device success
Time frame: Index Procedure
Technical success
Time frame: Index Procedure
Procedural success
Time frame: Index Procedure
Composite Endpoint POCE
Time frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up
Composite Endpoint MACE
Time frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up
Composite Endpoint TVF
Time frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up
Composite Endpoint TLF
Time frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up
Mortality
Time frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up
Myocardial Infarction
Time frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up
Revascularization
Time frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up
Stent thrombosis rates
Time frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up
Serious Adverse Events (SAEs)
Time frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
Individual participant dataSharing planned: No

Related trials for Coronary Artery Disease

Not yet recruitingPhase 1/2
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
Heterozygous Familial Hypercholesterolemia (HeFH)
Active, not recruitingPhase 3
Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events
Coronary Artery Disease
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Active, not recruiting
Troponin in Acute Chest Pain to Risk Stratify and Guide EffecTive Use of Computed Tomography Coronary Angiography
Coronary Artery Disease
Recruiting
A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Understanding and Management of Coronary Calcium (The Optimal Trial)
Cardiovascular Diseases, Myocardial Ischemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Jeffrey Mifek contact

919-313-2102

jmifek@micell.com

Christopher DiMatteo contact

480-765-8584

cdimatteo@namsa.com

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

Questions about this trial

What is this clinical trial studying?

A study testing MiStent II coronary artery stent and Xience or Promus coronary artery stents in people with Coronary Artery Disease, run by Micell Technologies.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jeffrey Mifek (919-313-2102, jmifek@micell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target Lesion Failure (TLF) (time frame: through 12-month visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03423511.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2020.