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

NCT03423511 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: MIS-US-2017-01
• Study Type: interventional
• Target: 1,300
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Coronary Artery Disease

Keywords

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

Outcome Measures

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.

  through 12-month visit

Secondary Outcomes (12)

• Device success

  Index Procedure

• Technical success

  Index Procedure

• Procedural success

  Index Procedure

• Composite Endpoint POCE

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

• Composite Endpoint MACE

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

Study Arms (2)

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

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

Device: Xience or Promus coronary artery stents

Interventions

MiStent II coronary artery stent DEVICE

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

MiStent II Coronary Artery Stent

Xience or Promus coronary artery stents DEVICE

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

Xience or Promus Coronary Artery Stents

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Micell Technologies: lead
• Baim Institute for Clinical Research: collaborator
• North American Science Associates Inc.: collaborator
• Yale Cardiovascular Research Group: collaborator

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Laura Mauri, MD, MSc

  Brigham and Women's Hospial

  STUDY CHAIR

• Dean Kereiakes, MD

  The Christ Hospital

  PRINCIPAL INVESTIGATOR

• David Kandzari, MD

  Piedmont Heart Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey Mifek

CONTACT

919-313-2102; jmifek@micell.com

Christopher DiMatteo

CONTACT

480-765-8584; cdimatteo@namsa.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This is a single-blind trial, such that the patient or patient's family will NOT be told which stent they have received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: MiStent group vs. the Xience/Promus group.

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: February 6, 2018
• Study Start: December 31, 2021
• Primary Completion: June 1, 2023
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 4, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share