Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2025-12-24 @ 12:56 PM
NCT ID:
NCT03879161
Eligibility Criteria:
Inclusion Criteria:
* Male or female participants, 18 years of age or older at the time of enrollment.
* Participants meeting all medical conditions for percutaneous angiography.
* International Normalized Ratio (INR) \<1.3.
* Written informed consent to participate in the study.
* Ability to comply with the requirements of the study procedures.
Exclusion Criteria:
* Fibrous tissue in access path.
* Active skin infection at the point of needle insertion.
* Hemophilia, thrombocytopenia, coagulopathy, or other elevated risk for bleeding or abnormal clotting
* Use of antithrombotic medication.
* For participants taking warfarin or other anticoagulant medication, INR \>1.3.
* Participants who cannot tolerate mild sedation.
* Participants with the following laboratory values, unless approved by hematologist: Platelet count \<100,000/mL, Activated Partial Thromboplastin Time (APTT) \>39 sec or Prothrombin Time (PT) \>15 sec
* Pregnancy or lactation
* Patient is unable to comply with requirements of the procedure, i.e. holding breath
* Participation in an investigational trial within 30 days of enrollment.
* Any form of substance abuse (including drug or alcohol abuse), psychiatric disorder, or any chronic condition that could, in the opinion of the investigator, of interfering with the conduct of the study.
* Participants who are uncooperative or cannot follow instructions.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03879161
Study Brief:
Protocol Section:
NCT03879161