An interventional study of coronary pressure/temperature sensor-tipped guidewire and Angiography-derived index of microcirculatory resistance (IMRangio) in Stable Angina and Coronary Artery Disease, sponsored by Lithuanian University of Health Sciences. Recruiting at 1 site in Lithuania. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2023-11-13.
Sponsored by Lithuanian University of Health Sciences · Not applicable, Interventional, and Treatment
The purpose of this observational study is to compare the impact of rotational atherectomy to conventional stenting and to investigate how it may affect coronary microcirculation in patients with calcified coronary artery lesions and stable CAD.
The study's objectives are to:
Patients with calcified lesions will be enrolled prospectively and will have serial invasive and non-invasive microvascular testing prior to and after rotational atherectomy or conventional stenting.
Rotational atherectomy (RA) is a medical procedure used to treat patients with severe atherosclerosis, a condition that causes plaque buildup within the artery walls, resulting in narrowing of the blood vessels and decreased blood flow to the heart. RA is a technique that involves breaking up and removing plaque from the artery with a small, high-speed rotating burr.
However, RA is not without risks. One of the major risks associated with RA is the potential damage to the artery wall and surrounding tissue. This can lead to complications such as bleeding, blood clots, or injury to the heart or other organs. Additionally, the high-speed rotation of the burr can generate heat, which may damage the artery wall or cause the release of harmful particles into the bloodstream.
Another hypothesized risk of RA is its impact on microcirculation, which refers to the smallest blood vessels in the body. RA can cause disruption to these vessels, leading to a decrease in blood flow and potentially causing damage to tissues and organs that depend on them.
The purpose of this study is to look into the effect of rotational atherectomy on coronary microcirculation.
343 studies on the registry are indexed under Angina, Stable; 56 are open to participants now.
This study's planned enrollment of 300 is above the median of 150 across 230 interventional studies indexed under Angina, Stable.
Browse Angina, Stable studies →Lithuanian University of Health Sciences is the lead sponsor of 105 studies on the registry; 32 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who are scheduled to have rotational atherectomy will be labeled in this group; patients in this group will have invasive and non-invasive microvascular testing before and after the rotational atherectomy procedure.
Diagnostic Test: coronary pressure/temperature sensor-tipped guidewire · Diagnostic Test: Angiography-derived index of microcirculatory resistance (IMRangio)
Patients who are scheduled to have conventional stenting will be labeled in this group; patients in this group will have invasive and non-invasive microvascular testing before and after the conventional stenting procedure.
Diagnostic Test: coronary pressure/temperature sensor-tipped guidewire · Diagnostic Test: Angiography-derived index of microcirculatory resistance (IMRangio)
In brief, a 6-F angioplasty guiding catheter without side-holes will be used first used to engage the left main coronary artery. A pressure-temperature sensor guidewire ( PressureWire™ X Guidewire) will be used for physiology measurements including IMR measurements. Pressure measurement from the wire will be first equalized with that of the guiding catheter. Then the pressure sensor will be positioned two-thirds of the way down the LAD artery. Intracoronary nitroglycerin will be administered (100 to 200 μg). Hyperemia will be induced with adenosine intracoronary injections.
Angiography-derived index of microcirculatory resistance (IMRangio) will be calculated by an anticipated software
The incidence of coronary microvascular dysfunction
Microcirculatory dysfunction will be defined as having an IMR value ≥ 25 U and a CFR value \< 2.5 U or angio IMR ≥ 25 U
Time frame: 1 day
Rate of Major adverse cardiovascular events
composite of nonfatal stroke, nonfatal myocardial infarction, heart failure, target vessel revascularization and cardiovascular death.
Time frame: 1 year
The incidence of coronary microvascular dysfunction
Microcirculatory dysfunction will be defined as having an IMR value ≥ 25 U and a CFR value \< 2.5 U or angio IMR ≥ 25 U
Time frame: 1 year
Seattle Angina Questionnaire score
Evaluates the severity of angina symptoms, physical limitations, and quality of life
Time frame: 1 year
Plan to share: Undecided
No publications or documents are linked to this record.
Started May 2023 (actual). Primary completion is estimated for May 2024, 12 months after the start.
Of 65 non-industry interventional studies with no phase under Angina, Stable, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 57. This study's planned 12 months is below that.
Counting every sponsor, half of 76 studies reached it within 35 months; a quarter within 14 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Lithuanian University of Health Sciences →