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3 Study Matches

THE MAGENTA ELEVATE HIGH-RISK PCI PIVOTAL TRIAL PROTOCOL (ELEVATE III)

For patients having a procedure to open severe blockages in the heart's arteries. Due to your severe blockages and weakened heart function, you may be at higher risk of having a drop in blood flow. THE MAGENTA ELEVATE device heart pump device is used during the procedure. This device is intended to prevent drops in blood flow during the procedure. It does this by assisting the heart in pumping blood through the body.

Contact(s):

MICHELLE BUTCHER - MBUTCHE1@HFHS.ORG

Principal Investigator: Mir Babar Basir
Principal Investigator ID: mbasir1@hfhs.org
Sex: Male or Female
Age: 18 years and over
Phase: N/A
Healthy Volunteers:
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Heart function less than 50%. Participant signed the informed consent. Additional criteria will be assessed prior to enrollment.
Exclusion Criteria:
You may not participate IF: 1. Age less than 18 and greater than 89 years old. 2. Cardiac arrest or Cardiogenic shock 3. Prior stroke or TIA within 3 months prior to enrollment. 4. Participant is presently or has recently been intubated. Additional criteria will be assessed prior to enrollment.
Interventions: Drug/Device: The Magenta Elevate? System
Conditions: HIGH RISK PCI, CAD, CORONARY STENOSIS
Keywords: CAD, CARDIAC CATHETERIZATION, CORONARY STENOSIS, PCI

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The Radial vs. State-Of-The-Art FEmoral Access for Bleeding and Access SIte Complication Reduction in Cardiac CaTHeterization (REBIRTH) Trial

The primary study objective is to evaluate whether radial access for cardiac catheterization of patients reduces vascular access complications and bleeding occurring within 72 h of the procedure or by hospital discharge, when compared with state-of-the-art femoral access. Patients randomized to femoral access will be further randomized to use of a micropuncture (21 gauge) vs. standard (18 gauge) needle.

Contact(s):

Michelle Butcher - mbutche1@hfhs.org

Principal Investigator: Khaldoon Alaswad
Principal Investigator ID: kalaswa1@hfhs.org
Sex: Male or Female
Age: 18 years and over
Phase: N/A
Healthy Volunteers:
This study is also accepting healthy volunteers
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Inclusion Criteria:

• Age greater than 18 years
• Patients undergoing cardiac catheterization
• Has provided informed consent and agrees to participate
• Patients must be equally eligible to undergo cardiac catheterization via radial or femoral access
Exclusion Criteria:

• Patients arriving for emergency heart attack
• Patients undergoing only planned right heart catheterization, with no plan for concurrent left heart catheterization
• Valvular heart disease requiring valve surgery within 30 days after the index procedure
• Hemodialysis access (arteriovenous fistula or graft) in the arm to be used for PCI in case of assignment to radial approach (the opposite arm may be used for radial access if a dialysis graft is present in one)
• Peripheral arterial disease prohibiting vascular access
Interventions: Drug/Device: N/A
Conditions: CAD, pre-op surgical evaluations, cardiac clearance, PCI, coronary stenosis
Keywords: CAD, Cardiac Catheterizion, cardiac clearance, coronary stenosis, Femoral, PCI, Radial

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AGENT DCB STANCE: AGENT Drug-Coated Balloon for STent AvoidANCE in PCI for De Novo Coronary Artery Disease

The AGENT DCB STANCE study will compare the AGENT Paclitaxel Coated Balloon Catheter to standard of care treatment with drug-eluting stents and/or balloon medical procedure to open blocked or narrowed blood vessels.

Contact(s):

Melanee Schimmel, BSN, RN - mschimm2@hfhs.org

Principal Investigator: Asaad Nakhle
Principal Investigator ID: anakhle2@hfhs.org
Sex: Male or Female
Age: 18 years and over
Phase: N/A
Healthy Volunteers:
This study is NOT accepting healthy volunteers
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Inclusion Criteria:

• Must be at least 18 yrs of age
• Understands and the willingness to comply with all study required follow-up evaluation
• Women of child-bearing potential must agree to use a reliable method of contraception for 1 year.
Exclusion Criteria:

• Other serious medical illness that may reduce life expectancy to less than 1 year.
• Serious problem with substances (alcohol, cocaine, heroin, etc.)
• Currently participating in another experimental drug/device study that has not met the outcome the study is measuring
• Is pregnant and nursing
• Has had a non-surgical procedure used to open narrowed or blocked coronary arteries with a balloon or stent
• Been diagnosed with severe heart failure within the past 6 months
• Known allergy to paclitaxel or other parts of the medical devices that are used.
• Severe renal failure
Interventions: Drug/Device: AGENT Drug-Coated Balloon
Conditions: Coronary Artery Disease
Keywords: , coronary artery disease (CAD), de novo lesions in native Coronary arteries, drug coated balloon, percutaneous coronary intervention (PCI)

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