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New treatment option for Coronary Arterial Disease (CAD)
Official title Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
ClinicalTrials.gov ID: NCT06939374
What this study is testing
- What it's testing
- ICECAP is a multi-centre, prospective, single-arm, interventional, traditional feasibility clinical investigation to evaluate the efficacy and safety of intra-coronary cryotherapy on vulnerable or high-risk plaque (HRP), using the CryoTherapy System (CTS). The study aims to enroll 25 patients with symptomatic coronary artery disease, successfully treated for their culprit lesion and with presence of at least one HRP lesion in another vessel.
- Time commitment: about 9 months
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
- 1) Subject is at least 18 years old. 2) Subject has acute cardiac pain/angina consistent with stable angina or acute coronary syndrome eligible for...
- Non-ST-segment elevation myocardial infarction (NSTEMI) with rise/fall of cardiac enzymes (troponin I or T) with at least one value above the 99th...
- Unstable angina
- ST-segment elevation myocardial infarction (STEMI) 3) Successful PCI (defined as diameter stenosis less than 30% and TIMI 3 flow on final angiography...
- Located in a non-culprit vessel,
You likely can't join if
- 1) Subject is hemodynamically unstable (cardiogenic shock, hypotension needing inotropes, hypoxia needing intubation, refractory ventricular...
- Visible distal embolization/no-reflow following culprit lesions PCI.
- Left main coronary artery disease (visual diameter stenosis \> 50%).
- Stent thrombosis/restenosis as a culprit lesion.
- CTS lesion involving a bifurcation (defined as lesions involving side branches \>2.0 mm).
- Angiographic or CCTA evidence of severe calcification and/or marked tortuosity of the index vessel and/or lesion.
See the full eligibility criteria
- 1) Subject is at least 18 years old. 2) Subject has acute cardiac pain/angina consistent with stable angina or acute coronary syndrome eligible for coronary angiography meeting one of the following criteria:
- Non-ST-segment elevation myocardial infarction (NSTEMI) with rise/fall of cardiac enzymes (troponin I or T) with at least one value above the 99th percentile of the upper reference limit requiring PCI within 72 hours...
- Unstable angina
- ST-segment elevation myocardial infarction (STEMI) 3) Successful PCI (defined as diameter stenosis less than 30% and TIMI 3 flow on final angiography without procedural complication) of the culprit lesion. NOTE: people...
- Located in a non-culprit vessel,
- High-risk plaque lesion on CCTA and at least one of the following features:
- Presence of low-attenuation plaque (HU\<50) and/or
- Positive remodelling (remodelling index \>1.1) and/or
- Napkin ring sign and/or
- Plaque burden ≥70%
- Lesion length ≤ 20 mm.
- Diameter stenosis on invasive angiography between 30% and 70% on coronary angiogram or negative physiology assessment (FFR\>0.80 or NHPR\>0.89).
- Reference vessel diameter (RVD) \ 2.50 mm in diameter
- Investigator considers that lesions are accessible.
- If more than two suitable lesions available, investigator will select the most appropriate lesion for cryotherapy treatment. 5) maxLCBI4mm in the lesion \> 324.7 6) Subject is able to provide consent and has signed and...
- 1) Subject is hemodynamically unstable (cardiogenic shock, hypotension needing inotropes, hypoxia needing intubation, refractory ventricular arrhythmias, and IABP). 2) Subject has ongoing ST-segment elevation myocardial...
- Visible distal embolization/no-reflow following culprit lesions PCI.
- Left main coronary artery disease (visual diameter stenosis \> 50%).
- Stent thrombosis/restenosis as a culprit lesion.
- CTS lesion involving a bifurcation (defined as lesions involving side branches \>2.0 mm).
- Angiographic or CCTA evidence of severe calcification and/or marked tortuosity of the index vessel and/or lesion.
- Thrombotic lesions.
- Ostial lesions.
The study team makes the final eligibility decision.
Where it's taking place
- Aalst, Belgium
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 study runs about 9 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Aalst, Belgium; London, United Kingdom. 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.