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Acute Coronary SyndromeICEBERGNCT04857580

Pilot Study on the Effect of Intracoronary Cryotherapy on Stabilization of Vulnerable Plaque at Risk of Rupture

A study testing CTS Device in people with Acute Coronary Syndrome, run by Cryotherapeutics SA at 3 sites in 2 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Atherosclerosis is a progressive inflammatory disease of the large and medium sized arteries, which is characterized by the formation of plaques in the vessel wall. The morphology and composition of the plaque play a major role in its stability during the development of the disease. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Coronary Syndrome
What is being tested?
CTS Device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
3 sitesin 2 countries
Study dates
1 Sep 2021to 15 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men or women at least 18 years old.
  • Acute cardiac pain/angina consistent with 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 Percutaneous Coronary Intervention (PCI) within 72 hours from diagnosis
  • Stabilized ST-segment elevation myocardial infarction (STEMI) with at least one value above the 99th percentile of the upper reference limit requiring PCI within < 12 hours from symptoms onset.
  • Unstable angina with new or worsening angina symptoms over the last 2 weeks requiring PCI within 72 hours.
  • Patient must have one, two or three-vessel disease in native coronary arteries.
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  • PCI of the culprit lesion on all patients.
  • At least one lesion meeting the criteria below:
  • Located in a non-culprit vessel, or proximal to the culprit lesion if located in the culprit vessel with at least 10 mm distance from the culprit lesion.
  • Lesion stenosis ≤ 70% of the reference vessel diameter by visual assessment on coronary angiogram.
  • Plaque-level maxLCBI4mm ≥ 325 by NIRS (Near-Infrared Spectroscopy).
  • Plaque burden ≥ 65% by IVUS (IntraVascular UltraSound).
  • Not intended for revascularization based on angiographic criteria and negative physiology assessment (FFR>0.80 or iFR/RFR>0.89).
  • Lesion-level balloon to artery ratio > 1.0.
  • Lesion length ≤ 20 mm.
  • Investigator considers that lesions are accessible.
  • If more than two suitable lesions available, investigator will select two lesions for randomization.
  • Subject able to consent and has a signed and dated the informed consent form.

Who cannot join

  • Unstable patients (cardiogenic shock, hypotension needing inotropes, hypoxia needing intubation, refractory ventricular arrhythmias, and IABP).
  • Patients with ongoing ST-segment elevation myocardial infarction.
  • Patients that had a procedural complication during the PCI procedure, such as coronary dissection, perforation or a complication that would necessitate immediate and/or unplanned surgical revascularization.
  • History of Coronary Artery Bypass Graft (CABG) or planned CABG within 12 months after the index procedure.
  • Known ejection fraction < 30%.
  • Known severe valvular heart disease.
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  • Known severe renal insufficiency (eGFR <30 ml/min/1.72 m2).
  • Any life-threatening conditions or medical comorbidity resulting in life expectancy < 12 months.
  • Participation in any investigational study that has not yet reached its primary endpoint.
  • Women who are pregnant or lactating, or NOT surgically sterile (tubal ligation or hysterectomy) or NOT postmenopausal for at least 6 months or women with childbearing potential without effective contraception (pill, patch, ring, diaphragm, implant and intrauterine device).
  • Angiographic exclusion criteria:
  • Visible distal embolization/no-reflow following culprit PCI.
  • Left main coronary artery disease (visual diameter stenosis > 50%).
  • Stent thrombosis/restenosis as a culprit lesion.
  • Index lesion involving a bifurcation.
  • Angiographic evidence of severe calcification and/or marked tortuosity of the index vessel and/or lesion.

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Denmark2 sites

  • Rigshospitalet

    Copenhagen

  • Zealand University Hospital

    Roskilde, 4000

Other trials in Denmark

Sweden1 site

  • Skåne University Hospital

    Lund, 22242

Other trials in Sweden

About this study

Official title: Intracoronary Cryotherapy Effect for staBilization of vulnErable Plaque at Risk of Rupture as Assessed by imaGing

Atherosclerosis is a progressive inflammatory disease of the large and medium sized arteries, which is characterized by the formation of plaques in the vessel wall. The morphology and composition of the plaque play a major role in its stability during the development of the disease.

The CTS system allows to deliver coronary cryotherapy intended for stabilization of vulnerable plaque with non-significant stenosis. Vulnerable plaque at high risk of rupture will be assessed by NIRS-IVUS imaging modality in patients with Acute Coronary Syndrome (ACS).

The ICEBERG study is an early feasibility single arm study enrolling a maximum of 45 patients. After enrolment of the first 5 patients in the First-in-Man safety cohort, the trial will enroll and randomize 40 eligible lesions in the randomized cohort of which 20 will be treated with cryotherapy.

Being tested
CTS Device
Medical subject headings
Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CTS DeviceDevice

    Coronary cryotherapy is delivered locally on eligible lesions randomized to the treatment using the CTS System.

Study groups in NCT04857580
Study groupRoleWhat they receive
CTS deviceExperimentalNot described
Receives: Device: CTS Device
ControlNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cryotherapy procedure related complication

    Any cryotherapy procedure related complication defined as coronary artery dissection, acute vessel closure, ischemia, arrythmia, need for bailout stenting, or any Major Adverse Cardiac Events (MACE) adjudicated to the index lesion

    Measured: 90 days

  2. Optical Coherence Tomography (OCT)-assessed fibrous cap thickness

    Change in Optical Coherence Tomography (OCT)-assessed fibrous cap thickness from index lesion.

    Measured: 90 days

Secondary outcomes (3)

  1. Cryotherapy related complication

    Any cryotherapy related complication defined as coronary artery dissection, acute vessel closure, ischemia, arrythmia, need for bailout stenting, or any MACE defined as cardiac death, myocardial infarction, revascularization, rehospitalization for unstable or progressive angina adjudicated to the index lesion.

    Measured: 9 months

  2. Device success

    Device success defined as ability to successfully track and treat the lesion.

    Measured: Baseline

  3. Cryotherapy/lesion procedure success

    Cryotherapy/lesion procedure success defined as TIMI 3 flow, percent diameter stenosis equivalent to or lower than pre-procedure.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2021
  2. Study start1 Sep 2021
  3. Primary completion15 Dec 2022
  4. Study completion15 Dec 2022

Why it stopped: No subjects enrolled

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04857580
Sponsor's protocol ID
CT-CD-P01-1
Acronym
ICEBERG
Status last verified
Feb 2023
First submitted
13 Apr 2021
Last updated
17 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Erlinge D, Maehara A, Ben-Yehuda O, Botker HE, Maeng M, Kjoller-Hansen L, Engstrom T, Matsumura M, Crowley A, Dressler O, Mintz GS, Frobert O, Persson J, Wiseth R, Larsen AI, Okkels Jensen L, Nordrehaug JE, Bleie O, Omerovic E, Held C, James SK, Ali ZA, Muller JE, Stone GW; PROSPECT II Investigators. Identification of vulnerable plaques and patients by intracoronary near-infrared spectroscopy and ultrasound (PROSPECT II): a prospective natural history study. Lancet. 2021 Mar 13;397(10278):985-995. doi: 10.1016/S0140-6736(21)00249-X.

    PubMed 33714389

  • Stone GW, Maehara A, Ali ZA, Held C, Matsumura M, Kjoller-Hansen L, Botker HE, Maeng M, Engstrom T, Wiseth R, Persson J, Trovik T, Jensen U, James SK, Mintz GS, Dressler O, Crowley A, Ben-Yehuda O, Erlinge D; PROSPECT ABSORB Investigators. Percutaneous Coronary Intervention for Vulnerable Coronary Atherosclerotic Plaque. J Am Coll Cardiol. 2020 Nov 17;76(20):2289-2301. doi: 10.1016/j.jacc.2020.09.547. Epub 2020 Oct 15.

    PubMed 33069847

Questions about this trial

What is this clinical trial studying?

A study testing CTS Device in people with Acute Coronary Syndrome, run by Cryotherapeutics SA at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Denmark, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cryotherapy procedure related complication (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04857580, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2023.

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