Status:
NOT_YET_RECRUITING
Trial to Demonstrate the Safety and Effectiveness of the MiStent II for the Revascularization of Coronary Arteries.
Lead Sponsor:
Micell Technologies
Collaborating Sponsors:
Baim Institute for Clinical Research
North American Science Associates Inc.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 nov...
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 availab...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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)
- 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)
Key Trial Info
Start Date :
December 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
1300 Patients enrolled
Trial Details
Trial ID
NCT03423511
Start Date
December 31 2021
End Date
June 1 2027
Last Update
September 4 2020
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