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New treatment option for Coronary Artery Disease
Official title INSIGHTFUL-FFR Clinical Trial
ClinicalTrials.gov ID: NCT05437900
What this study is testing
- What it's testing
- Recently, a new device for measuring physiological lesion severity, the pressure microcatheter, was introduced. The pressure microcatheter provides similar information to the conventional measurement technique but differs as it is easily advanced on a customary coronary wire and simplifies pullback maneuvers.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- The subject must be at least 18 years of age and younger than 85 years old.
- Eligible for elective PCI.
- Stable angina or ACS (non-culprit vessels only and outside of primary intervention during acute STEMI)
- Subject willing to participate and able to understand, read and sign the Informed Consent.
You likely can't join if
- STEMI as clinical presentation.
- Chronic total occlusion as a target vessel.
- Significant contraindication to adenosine administration (e.g. heart block, severe asthma)
- Uncontrolled or recurrent ventricular tachycardia.
- Hemodynamic instability.
- Severe valvular disease.
See the full eligibility criteria
- The subject must be at least 18 years of age and younger than 85 years old.
- Eligible for elective PCI.
- Stable angina or ACS (non-culprit vessels only and outside of primary intervention during acute STEMI)
- Subject willing to participate and able to understand, read and sign the Informed Consent.
- STEMI as clinical presentation.
- Chronic total occlusion as a target vessel.
- Significant contraindication to adenosine administration (e.g. heart block, severe asthma)
- Uncontrolled or recurrent ventricular tachycardia.
- Hemodynamic instability.
- Severe valvular disease.
- Severe renal dysfunction defined as an eGFR ≤30 mL/min/1.73 m2.
- Comorbidity with life expectancy ≤ 2 years.
- Inability to take DAPT (both aspirin and a P2Y12 inhibitor) for at least 12 months in the patient presenting with an ACS, or at least six months in the patient presenting with stable CAD, unless the patient is also...
- Planned major cardiac or non-cardiac surgery within 24 months after the index procedure. Note: major surgery is any invasive procedure in which an extensive resection is performed, e.g., a body cavity is entered, organs...
- Subject has known hypersensitivity or contraindication to any of the study drugs (including all P2Y12 inhibitors, one or more components of the study devices, including everolimus, zotarolimus, biolimus, sirolimus...
- The subject has received a functioning solid organ transplant or is active on a waiting list for any solid organ transplants with expected transplantation within 24 months.
- The subject receives immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus...
- The subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy) or the chest/mediastinum.
- Subject has a platelet count \ 700,000 cells/mm3.
- The subject has a documented or suspected hepatic disorder defined as cirrhosis or Child-Pugh ≥ Class B.
- The subject has a history of bleeding diathesis or coagulopathy or has had a significant gastro-intestinal or significant urinary bleed within the past six months. The subject has had a cerebrovascular accident or...
- The subject is currently participating in another investigational drug or device clinical study.
- Pregnancy or nursing.
- Presence of other anatomic or comorbid conditions or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation...
The study team makes the final eligibility decision.
Where it's taking place
- Aalst, Oost-Vlaanderen, Belgium
- Brussels, Belgium
- Genk, Belgium
- Shanghai, Xuhui District, China
- Shandong, China
- Sichuan, China
- Lille, France
- Lyon, France
- Paris, France
- Dresden, Germany
- Fürth, Germany
- Herford, Germany
- Koblenz, Germany
- Lahr, Germany
- Mainz, Germany
- Ferrara, Italy
- La Spezia, Italy
- Latina, Italy
- Naples, Italy
- Rome, Italy
+ 7 more site(s).
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aalst, Oost-Vlaanderen, Belgium; Brussels, Belgium; Genk, Belgium; Shanghai, Xuhui District, China; Shandong, China; Sichuan, China and 21 more location(s). 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.