Status:
TERMINATED
Intravascular Ultrasound-Guided Intervention for Venous Leg Ulcers (IGuideU)
Lead Sponsor:
Philips Clinical & Medical Affairs Global
Conditions:
Venous Ulcer of Leg
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
This clinical study is a global, prospective, multi-center, randomized controlled trial to determine if the use of intravascular ultrasound (IVUS) as an adjunctive imaging modality and as an intervent...
Detailed Description
This study will be conducted in 266 subjects presenting with venous ulcers that have previously undergone treatment for superficial of and/or perforator venous disease, if clinically indicated, follow...
Eligibility Criteria
Inclusion
- Be between 18 and 85 years of age.
- Able and willing to participate and comply with the protocol, including the defined follow-up schedule, by signing an Institutional Review Board (IRB) or Ethics Committee approved informed consent form.
- Active venous leg ulcer (CEAP C6).
- Previously completed treatment for clinically significant reflux in the superficial and/or perforator venous system of the target limb at least 3 months prior to enrollment, if clinically indicated.
- Completed at least 3 months of prescribed compression therapy after any ablation.
- Palpable dorsalis pedis or posterior tibial artery (DP/PT) pulses at ipsilateral foot or ankle brachial index (ABI) ≥0.8.
- Be able to ambulate unassisted or with non-motorized assistive devices.
- Current VLU present ≤48 months.
Exclusion
- Patient is known pregnant or breast-feeding or planning to become pregnant in the following year.
- If antiplatelet and anticoagulation therapy cannot be tolerated.
- Previous venous stent implantation involving the target limb, target lesion, or inferior vena cava.
- Previous venovenous bypass surgery involving the target limb.
- Previous endovascular recanalization of the target lesion segment.
- Known metal allergy precluding stent implantation.
- Known or suspected to have inadequate inflow to support stent patency in the target limb.
- Active cancer diagnosis.
- Known positive test for COVID-19 (Sars-CoV-2) within the last 2 weeks and actively symptomatic.
- Known or suspected venous outflow obstruction caused by tumor compression/encasement with or without thrombus.
- Known allergy to contrast media that cannot adequately be pre-medicated prior to study procedure.
- Known renal dysfunction (defined as eGFR \<30mL/min/1.73m2) that would preclude adequate contrast usage.
- Diagnosed with right heart failure/pulmonary hypertension.
- Has known clinically significant abnormal platelet count outside laboratory reference ranges.
- Has known clinically significant abnormal white blood cell count (WBC), fever, sepsis or positive blood culture.
- Organ transplant requiring immunosuppressant therapy.
- Unstable angina pectoris, or myocardial infarction within 30 days and/or hemorrhagic stroke within 3 months.
- Subjects with an active diagnosis of osteomyelitis of the ipsilateral limb.
- Previous or planned surgical or catheter-based procedure on index leg within 30 days before or 30 days after the index procedure.
- Active participation in another investigational drug or device study.
- Subject has any condition, which, in the opinion of the investigator, precludes the subject from participation.
Key Trial Info
Start Date :
October 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 17 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04696354
Start Date
October 12 2021
End Date
January 17 2023
Last Update
October 1 2024
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
Vascular Care Connecticut
Darien, Connecticut, United States, 06820
2
Florida Cardiology, P.A.
Winter Park, Florida, United States, 32792
3
Northwestern
Chicago, Illinois, United States, 60208
4
Cardiovascular Institute of the South
Houma, Louisiana, United States, 70394