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New treatment option for Peripheral Artery Disease
Official title Stents Post-dilation With DCB or POBA in Femoropopliteal Arteries
ClinicalTrials.gov ID: NCT03791970
What this study is testing
- What it's testing
- To compare the efficacy and safety of stent angioplasty with Orchid 035 Drug Coated Dilatation (DCB) and Plain Old Balloon Angioplasty (POBA) for post-dilatation for long (\>10cm) femoropopliteal chronic total occlusion.
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
- Age ≥18 years;
- The subject is legally competent and able to understand the information on the study, has been informed of the nature, the scope and the relevance of...
- Rutherford Category 2-4;
- Target de novo lesion(s) or non-stented restenotic lesion(s) has angiographic evidence of long-term occlusion (by visual estimate ≥10cm) and is...
- Patients must be able to be treated with DCB or POBA for post-dilation;
You likely can't join if
- Pregnant, lactating, or planning on becoming pregnant or men intending to father children;
- Contraindication to stent or DCB or POBA per current information for use (IFU);
- Life expectancy of \<1 year;
- Inability to take required antiplatelet/anticoagulant medications, or known contraindication (including allergic reaction) or sensitivity to contrast...
- Intended treatment of outflow disease during the index procedure;
- Intended use of laser, atherectomy or cryoplasty during index procedure;
See the full eligibility criteria
- Age ≥18 years;
- The subject is legally competent and able to understand the information on the study, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's...
- Rutherford Category 2-4;
- Target de novo lesion(s) or non-stented restenotic lesion(s) has angiographic evidence of long-term occlusion (by visual estimate ≥10cm) and is amenable to treatment with stents placement;
- Patients must be able to be treated with DCB or POBA for post-dilation;
- Target vessel reference diameter is 4.0-7.0 mm (by visual estimate) and able to be treated with available device size matrix;
- At least one patent native outflow artery to the ankle free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of outflow disease is NOT permitted; treatment of in-flow disease is permitted...
- No other prior vascular interventions (including contralateral limb) within 2 weeks before and/or planned 30 days after the protocol treatment, with the exception of remote common femoral patch angioplasty separated by...
- Female people of childbearing potential have a negative urine or serum pregnancy test within 7 days prior to index procedure;
- Lesion location starts ≥1 cm below the common femoral bifurcation and P1 popliteal artery.
- Pregnant, lactating, or planning on becoming pregnant or men intending to father children;
- Contraindication to stent or DCB or POBA per current information for use (IFU);
- Life expectancy of \<1 year;
- Inability to take required antiplatelet/anticoagulant medications, or known contraindication (including allergic reaction) or sensitivity to contrast media, nickel, titanium or tantalum that cannot be adequately managed...
- Intended treatment of outflow disease during the index procedure;
- Intended use of laser, atherectomy or cryoplasty during index procedure;
- Sudden symptom onset, acute vessel occlusion, or acute or subacute thrombus in target vessel;
- History of stroke within 3 months;
- History of myocardial infarction, thrombolysis or angina within 2 weeks of enrollment;
- Participation in an investigational drug or another investigational device study until this study's primary endpoint is reached or previous enrollment in this study;
- Another medical condition, which, in the opinion of the Investigator, may cause the patient to be noncompliant with the Concern/Information Need/Participation Willingness (CIP) or confound data interpretation;
- Target vessel and/or lesion involves a previously placed stent.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
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 Shanghai, Shanghai Municipality, China. 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.