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 @ 10:32 PM
Ignite Modification Date:
2025-12-24 @ 10:32 PM
NCT ID:
NCT01436435
Eligibility Criteria:
Inclusion Criteria:
* Patient is ≥ 18 years of age.
* The target de novo or restenotic Percutaneous Transluminal Angioplasty (PTA) lesion(s) is/are located in the common femoral, superficial femoral or popliteal arteries.
* The reference vessel lumen (proximal to target lesion) is ≥ 4.0mm.
* Evidence of ≥ 70% stenosis or occlusion confirmed by angiography.
* Guidewire must cross lesion(s) within the true lumen, without a sub-intimal course before the patient is considered as entered into the study.
* Patient is an acceptable candidate for percutaneous intervention using the Jetstream NAVITUS System in accordance with its labeled indications and instructions for use.
* Lesion length ≥ 4cm.
* Patient has a Rutherford category score of 1-3.
* Patient has signed approved informed consent.
* Patient is willing to comply with the follow-up evaluations at specified times.
Exclusion Criteria:
* Patient has an uncontrollable allergy to nitinol, stainless steel or other stent materials or to contrast agent.
* Patient is unable to take appropriate anti-platelet therapy.
* Patient has no patent distal runoff vessels.
* Patient has critical limb ischemia (i.e., Rutherford class 4-6)
* Limited vascular access that precludes safe advancement of the Jetstream NAVITUS System to the target lesion(s).
* Interventional treatment is intended for in-stent restenosis.
* Patient has target vessel with moderate or severe angulation (e.g., \>30 degrees) or tortuosity at the treatment segment.
* Patient has a history of coagulopathy or hypercoagulable bleeding disorder.
* Patient is receiving hemodialysis or has significantly impaired renal function (creatinine is \> 2.5 mg/dl) at the time of treatment.
* Patient has evidence of intracranial or gastrointestinal bleeding within the past 3 months.
* Patient has had severe trauma, fracture, major surgery or biopsy of a parenchymal organ within the past 14 days.
* Patient has had surgical or endovascular procedure in the same vascular territory within 30 days prior to the index procedure.
* Patient has any planned surgical intervention or endovascular procedure within 30 days after the index procedure.
* Use of another debulking device during the index procedure prior to the Jetstream NAVITUS System will exclude the patient.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01436435
Study Brief:
Protocol Section:
NCT01436435