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 @ 7:01 PM
Ignite Modification Date:
2025-12-24 @ 7:01 PM
NCT ID:
NCT03933657
Eligibility Criteria:
Inclusion Criteria:
General Inclusion Criteria
* Has symptomatic non-acute limb ischemia, requiring treatment of an infrainguinal artery
* Has Rutherford Clinical Category of 2-6
* is able and willing to provide written informed consent prior to study procedure
Angiographic Inclusion Criteria
* 100% stenosis by a visual estimate of angiography at the time of the procedure
* target CTO has moderate to severe calcification
* Has at least one of the following: severe calcification, flush occlusion, femoropopliteal CTOs with reconstitution below Popliteal 2-3, side directing collateral at the proximal cap, long (≥ 5cm) occlusions, below the knee (BTK) occlusion.
* Has evidence of a clinically significant CTO located in a peripheral vessel below the infrainguinal ligament confirmed by angiography at time of the procedure.
Exclusion Criteria:
General Exclusion Criteria
* Insufficient kidney function or renal failure
* Subject has positive pregnancy test result
* Participation in any study of a study device, medication, biologic, or other agent during study or within 30 days prior to enrollment that is either a cardiovascular study or could, in the judgment of the investigator, affect the results of this study
* Subject in whom antiplatelet, anticoagulant therapy is contraindicated
* Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/ml or known coagulopathy
* Known, untreated allergy to contrast agents or medications used during or subsequent to endovascular intervention. Patients with aspirin allergy that have been desensitized are not excluded.
* History of heparin-induced thrombocytopenia (HIT) that cannot be treated with direct thrombin inhibitors.
* Psychiatric disorder which in the judgment of the investigator could interfere with provision of informed consent, completion of tests, therapy or general study compliance.
Angiographic Exclusion Criteria
* The target CTO is located \< 3 cm from a stented segment.
* Has an acute or sub-acute intraluminal thrombus within the target vessel.
* Clinical/ angiographic evidence of distal embolization in the index extremity unresolved prior to crossing.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03933657
Study Brief:
Protocol Section:
NCT03933657