Phase 4 Heart Disease Trial, Recruiting NCT05437900 Sponsor: CoreAalst BV Condition: Heart Disease
Back to Heart Disease

Phase 4 Heart Disease Trial, Recruiting

NCT05437900
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are at least 18 years old and younger than 85 years old.
  • You are scheduled for a planned (non-emergency) heart procedure to open blocked arteries (called PCI).
  • You have either stable chest pain (stable angina) or a recent heart event (such as a heart attack), with specific conditions on which blood vessels are being treated (confirm with trial site).
  • You are willing to take part and are able to understand, read, and sign a consent form.

Who may not be able to join:

  • You are currently having a severe type of heart attack called a STEMI.
  • The artery being treated is completely blocked long-term (a "chronic total occlusion").
  • You have a serious reason why you cannot receive a medication called adenosine, such as a heart rhythm problem (heart block) or severe asthma.
  • You have uncontrolled or recurring dangerous heart rhythm problems (ventricular tachycardia).
  • Your heart or blood circulation is currently unstable.
  • You have a serious heart valve problem.
  • Your kidneys are not working well (confirmed by a specific blood test showing poor kidney function).
  • You have another illness that means your life expectancy is 2 years or less.
  • You are unable to take two specific blood-thinning medications together for the required period of time (confirm with trial site).
  • You are planning to have a major surgery within 24 months after this procedure.
  • You have a known allergy or serious reaction to any of the medications or materials used in this study, including certain metals, drug coatings, or contrast dye used in imaging (confirm with trial site).
  • You have had a solid organ transplant (such as a kidney or liver) or are expected to receive one within 24 months.
  • You take medications that suppress your immune system, or you have a serious autoimmune disease requiring ongoing treatment (note: steroid medications are not included in this restriction).
  • You have previously had or are planned to have radiation treatment directed at the heart arteries or chest area.
  • Your platelet count (cells that help blood clot) is too low or too high based on a blood test.
  • You have a serious liver condition such as cirrhosis or significant liver disease.
  • You have a history of serious bleeding problems, had a significant bleed in your stomach or urinary tract in the past 6 months, had a stroke or mini-stroke (TIA) in the past 6 months, any previous bleeding in the brain, any permanent neurological damage, or a known condition inside the skull (such as an aneurysm).
  • You are currently taking part in another clinical trial for a drug or medical device.
  • You are pregnant or breastfeeding.
  • You have other medical, personal, or psychological conditions that the study doctor believes could affect your ability to safely participate or complete the study (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 5 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Emanuele Barbato, MD, PhD, Azienda Ospedaliera Universitaria Sant'Andrea, Roma

Phone: 0032 53 72 42 30

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
CoreAalst BV
Registry
ClinicalTrials.gov
Start date
22 September 2022
Est. completion
30 June 2026

Where this trial is recruiting

🇧🇪 Belgium 🇨🇳 China 🇫🇷 France 🇩🇪 Germany 🇮🇹 Italy 🇳🇱 Netherlands 🇵🇱 Poland 🇪🇸 Spain

Primary endpoints

Compare the rate of MACE between pressure microcatheter and pressure wire strategies.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 5 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov