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

Not Applicable

Not yet recruiting

• Conditions: Coronary Artery Disease
• Interventions: Device: Xience or Promus coronary artery stents; Device: MiStent II coronary artery stent

• Registration Number: NCT03423511
• Lead Sponsor: 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)

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 Timeline

• Study First Submitted: 2018-01-23
• Study First Submitted QC: 2018-01-30
• Study First Posted: 2018-02-06
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-03
• Last Update Posted: 2020-09-04
• Study Start: 2021-12-31
• Primary Completion: 2023-06-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1300

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xience or Promus Coronary Artery Stents	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
MiStent II Coronary Artery Stent	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

Primary Outcome Measures

Name	Time	Method
Target Lesion Failure (TLF)	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

Name	Time	Method
Myocardial Infarction	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
Composite Endpoint TLF	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
Mortality	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)
Technical success	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.
Composite Endpoint TVF	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
Serious Adverse Events (SAEs)	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
Device success	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.
Procedural success	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.
Composite Endpoint POCE	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
Composite Endpoint MACE	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
Revascularization	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
Stent thrombosis rates	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