Clinical trial NCT03423511: Trial to Demonstrate the Safety and Effectiveness of the MiStent II for the Revascularization of Coronary Arteries.
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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Keywords: MiStent
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Lead sponsor: Micell Technologies
Sponsor class: INDUSTRY
Collaborators: name: Baim Institute for Clinical Research
name: North American Science Associates Inc.
name: Yale Cardiovascular Research Group
First posted: 2018-02-06
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: MiStent group vs. the Xience/Promus group.
Primary purpose: TREATMENT

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)

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.

Eligibility 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)

Primary outcomes:
measure: Target Lesion Failure (TLF)
timeFrame: through 12-month visit
Secondary outcomes:
measure: Device success
timeFrame: Index Procedure
measure: Technical success
timeFrame: Index Procedure
measure: Procedural success
timeFrame: Index Procedure
measure: Composite Endpoint POCE
timeFrame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up
measure: Composite Endpoint MACE
timeFrame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up
measure: Composite Endpoint TVF
timeFrame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up
measure: Composite Endpoint TLF
timeFrame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up
measure: Mortality
timeFrame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up
measure: Myocardial Infarction
timeFrame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up
measure: Revascularization
timeFrame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up
measure: Stent thrombosis rates
timeFrame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up
measure: Serious Adverse Events (SAEs)
timeFrame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Brigham and Women's Hospial
name: Laura Mauri, MD, MSc
role: STUDY_CHAIR
affiliation: The Christ Hospital
name: Dean Kereiakes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Piedmont Heart Institute
name: David Kandzari, MD
role: PRINCIPAL_INVESTIGATOR
References: