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New treatment option for Ischemic Cardiovascular Disease
Official title Temporary MCS With the iVAC 2L Transaortic Device in High-risk PCI
ClinicalTrials.gov ID: NCT07149714
What this study is testing
- What it's testing
- Patients with coronary artery disease and undergoing high-risk percutaneous coronary intervention (PCI) are at increased risk of hemodynamic instability and poor outcomes. Mechanical circulatory support (MCS) devices may offer hemodynamic stabilization during PCI, potentially improving short- and long-term outcomes.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Multidisciplinary heart team consensus for high-risk PCI. HR-PCI was defined as any percutaneous intervention for coronary disease involving an...
- Signed Informed Consent to participate in the study
You likely can't join if
- Femoral artery diameter \< 6.0mm
- Significant biventricular or right heart failure
- Thrombus in the left ventricle
- Presence of a mechanical aortic valve
- Aortic valve stenosis/calcification (equivalent to an orifice area of 0.6 cm2 or less) or moderate-to-severe aortic insufficiency (echocardiographic...
- Severe peripheral arterial disease precluding placement of the iVAC2L
See the full eligibility criteria
- Multidisciplinary heart team consensus for high-risk PCI. HR-PCI was defined as any percutaneous intervention for coronary disease involving an unusually high risk of periprocedural circulatory collapse.
- Signed Informed Consent to participate in the study
- Femoral artery diameter \< 6.0mm
- Significant biventricular or right heart failure
- Thrombus in the left ventricle
- Presence of a mechanical aortic valve
- Aortic valve stenosis/calcification (equivalent to an orifice area of 0.6 cm2 or less) or moderate-to-severe aortic insufficiency (echocardiographic assessment graded as ≥+2)
- Severe peripheral arterial disease precluding placement of the iVAC2L
- Combined cardiorespiratory failure
- Presence of an atrial or ventricular septal defect (including post infarct VSD)
- Left ventricular rupture
- Cardiac tamponade
- Presence of any other subtype of shock
- Known severe comorbidities independently affecting prognosis (chronic renal or liver failure, active malignancies etc.)
- Recent major bleeding event (\< 3 months)
- Recent stroke (\< 3 months)
The study team makes the final eligibility decision.
Where it's taking place
- Moscow, Russia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Moscow, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.