BridgeMD
Tests treatment safety and results for Peripheral Arterial Disease
Official title Post-market Registry Study on the Safety and Efficacy of ZENFLEX Pro™ Peripheral Drug-eluting Stent System for Femoropopliteal Artery Lesions
ClinicalTrials.gov ID: NCT07122167
What this study is testing
- What it's testing
- This is a prospective, multi-center, single-arm post-market study evaluating the safety and effectiveness of the ZENFLEX Pro™ Drug-eluting Stent in treating femoropopliteal artery stenosis or occlusion. A total of 153 subjects will be followed at 1, 6, and 12 months.
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 80
You may be able to join if
- (1) Aged 18 to 80 years, regardless of gender. (2) Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2, 3, 4 or 5. (3)...
- Stenotic, restenotic or occlusive lesion(s) located in the native superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) (i.e...
- Degree of stenosis ≥70% by visual angiographic assessment.
- Vessel diameter ≥4.0 mm and ≤6.5 mm.
- Total lesion length (or series of lesions) ≥ 10 mm and ≤ 140 mm (Note: Lesion segment(s) must be fully covered with one stent).
You likely can't join if
- Clinical exclusion criteria: people will be excluded from the study if any of the following conditions are present:
- Pregnant or breastfeeding women, or women/men planning to conceive.
- people who have had or are planned for major amputation (at or above the ankle level).
- people known to be allergic or intolerant to materials used in the investigational device or treatment drugs, including nitinol, paclitaxel, aspirin...
- people with serum creatinine ≥2.5 mg/dL or currently undergoing dialysis.
- people with known, uncorrectable hemorrhagic disorders or severe coagulation dysfunction (prothrombin time (PT) or activated partial thromboplastin...
See the full eligibility criteria
- (1) Aged 18 to 80 years, regardless of gender. (2) Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2, 3, 4 or 5. (3) Subject (or legal guardian, if applicable) is willing and able to provide...
- Stenotic, restenotic or occlusive lesion(s) located in the native superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) (i.e., within the P1 segment):
- Degree of stenosis ≥70% by visual angiographic assessment.
- Vessel diameter ≥4.0 mm and ≤6.5 mm.
- Total lesion length (or series of lesions) ≥ 10 mm and ≤ 140 mm (Note: Lesion segment(s) must be fully covered with one stent).
- Chronic total occlusion with a total lesion length of ≤120 mm.
- Patent popliteal and infrapopliteal arteries, with single-vessel runoff or better, defined as at least one of the three vessels remaining patent (i.e., \<50% stenosis) down to the ankle or foot.
- Clinical exclusion criteria: people will be excluded from the study if any of the following conditions are present:
- Pregnant or breastfeeding women, or women/men planning to conceive.
- people who have had or are planned for major amputation (at or above the ankle level).
- people known to be allergic or intolerant to materials used in the investigational device or treatment drugs, including nitinol, paclitaxel, aspirin, clopidogrel, heparin, rivaroxaban, contrast agents, etc.
- people with serum creatinine ≥2.5 mg/dL or currently undergoing dialysis.
- people with known, uncorrectable hemorrhagic disorders or severe coagulation dysfunction (prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≥2 times the upper limit of normal, or platelet count...
- Previously stented target lesion/vessel.
- Target lesion/vessel previously treated with drug-coated balloon \<12 months prior to enrollment.
- people with a life expectancy of less than 1 year.
- people who have received local or systemic thrombolysis treatment within 48 hours prior to enrollment.
- people diagnosed with major clinical diseases or unstable conditions within the past 3 months, such as severe heart failure, unstable angina, myocardial infarction, transient ischemic attack or stroke, severe...
- people currently participating in another clinical trial involving drugs or medical devices.
- people whom the investigator considers unsuitable for participation in the clinical trial. Angiographic exclusion criteria:
- Presence of aneurysm in the target vessel.
- Heavily calcified lesions (Peripheral Arterial Calcium Scoring System [PACSS] grades 3-4).
- The target lesion requires the use of plaque excision, laser, or other debulking devices that may damage the vessel intima.
- The guidewire cannot pass through the target lesion, or percutaneous transluminal angioplasty (PTA) balloon cannot be used for pre-dilation.
- Acute ischemia and/or acute thrombosis of the SFA/PPA prior to enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Chrzanów, Chrzanow, Poland
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 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chrzanów, Chrzanow, Poland. 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.