Using cold therapy inside coronary arteries to stabilize high‑risk plaque in people with angina or recent heart attack

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multi-center, single-arm feasibility investigation of intracoronary cryotherapy using the CryoTherapy System in 25 patients with symptomatic coronary artery disease. Eligible patients have had successful PCI of their culprit lesion and at least one non–flow-limiting high‑risk plaque in another vessel identified by imaging. Participants undergo baseline NIRS and OCT imaging, receive cryotherapy during a planned procedure within 8 weeks of eligibility, and return for repeat NIRS/OCT at 9 months with clinical follow-up at 1, 3, 6, 9, and 12 months. The primary endpoint is a 30% reduction in maxLCBI4mm on NIRS at 9 months, with secondary measures including fibrous cap thickness, plaque volume/composition by OCT, and safety/MACE outcomes.

Why it matters

Who can join: the full rules

Inclusion 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:

  1. 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 from diagnosis
  2. Unstable angina
  3. 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: subjects with unstable angina, for whom the culprit lesion as assessed by investigator does not require PCI currently or within the next 6 months (subject treated with optimal medical treatment) can be enrolled in the study.

4\) Subject has at least one high-risk plaque meeting the criteria below:

1. Located in a non-culprit vessel,
2. High-risk plaque lesion on CCTA and at least one of the following features:

   1. Presence of low-attenuation plaque (HU\<50) and/or
   2. Positive remodelling (remodelling index \>1.1) and/or
   3. Napkin ring sign and/or
   4. Plaque burden ≥70%
3. Lesion length ≤ 20 mm.
4. Diameter stenosis on invasive angiography between 30% and 70% on coronary angiogram or negative physiology assessment (FFR\>0.80 or NHPR\>0.89).
5. Reference vessel diameter (RVD) \< 3.75 mm and \> 2.50 mm in diameter
6. Investigator considers that lesions are accessible.
7. 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 dated the informed consent form.

   Exclusion Criteria:
   * 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 infarction. 3) Subject had a procedural complication during the ACS PCI procedure. 4) Subject has history of Coronary Artery Bypass Graft (CABG) or planned CABG within 12 months after the index procedure.

     5\) Subject has known reduced Left Ventricular Ejection Fraction \< 30%. 6) Subject has known severe valvular heart disease. 7) Subject has known severe renal insufficiency (eGFR \<30 ml/min/1.72 m2). 8) Subject has any life-threatening conditions or medical comorbidity resulting in life expectancy \< 12 months.

     9\) Subject is currently participating in another clinical investigation that has not yet reached its primary endpoint.

     10\) Subject has severe peripheral vascular disease impeding femoral artery access.

     11\) Subject is pregnant or lactating, or NOT surgically sterile (tubal ligation or hysterectomy) or NOT postmenopausal for at least 6 months or is a female with childbearing potential without effective contraception (pill, patch, ring, diaphragm, implant and intrauterine device).

   Angiographic exclusion criteria:
   1. Visible distal embolization/no-reflow following culprit lesions PCI.
   2. Left main coronary artery disease (visual diameter stenosis \> 50%).
   3. Stent thrombosis/restenosis as a culprit lesion.
   4. CTS lesion involving a bifurcation (defined as lesions involving side branches \>2.0 mm).
   5. Angiographic or CCTA evidence of severe calcification and/or marked tortuosity of the index vessel and/or lesion.
   6. Thrombotic lesions.
   7. Ostial lesions.

Where it's running

• AZORG Aalst
  Aalst, Belgium Recruiting
• St Bartholomew's Hospital
  London, United Kingdom Not yet recruiting
• Royal Brompton Hospital
  London, United Kingdom Not yet recruiting

Study contacts

• Study coordinator: Danny Detiege, RN
• Email: dde@cryotherapeutics.com
• Phone: +32 467 02 47 73

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.