Stents Post-dilation With DCB or POBA in Femoropopliteal Arteries

Launched by SHANGHAI NINTH PEOPLE'S HOSPITAL AFFILIATED TO SHANGHAI JIAO TONG UNIVERSITY · Jan 1, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at two different methods to treat a condition called Peripheral Artery Disease (PAD), which affects blood flow in the legs. Specifically, the study is comparing the use of a special drug-coated balloon (DCB) and a standard balloon approach (POBA) after placing a stent in the femoropopliteal arteries, which are the blood vessels in the thigh and knee area. The goal is to see which method is safer and more effective for patients with long-term blockages (over 10 centimeters) in these arteries.

To participate in this trial, individuals must be at least 18 years old and have specific blockages in their arteries that can be treated with stents. Eligible participants should also have at least one healthy artery leading to the ankle. It's important that they understand the study and agree to take part. If you join the trial, you can expect to receive thorough care and monitoring throughout the process. This study is currently recruiting participants, and it aims to provide valuable insights into improving treatment options for patients with PAD.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 years;
• • 2. 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 provisions, and has duly signed the Informed Consent Form (ICF);
• • 3. Rutherford Category 2-4;
• • 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;
• • 5. Patients must be able to be treated with DCB or POBA for post-dilation;
• • 6. Target vessel reference diameter is 4.0-7.0 mm (by visual estimate) and able to be treated with available device size matrix;
• • 7. 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 prior to treatment with stents placement).
• • 8. 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 at least 2 cm from the target lesion;
• • 9. Female subjects of childbearing potential have a negative urine or serum pregnancy test within 7 days prior to index procedure;
• • 10. Lesion location starts ≥1 cm below the common femoral bifurcation and P1 popliteal artery.
• Exclusion Criteria:
• • 1. Pregnant, lactating, or planning on becoming pregnant or men intending to father children;
• • 2. Contraindication to stent or DCB or POBA per current information for use (IFU);
• • 3. Life expectancy of \<1 year;
• • 4. 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 with pre- and post-procedure medication;
• • 5. Intended treatment of outflow disease during the index procedure;
• • 6. Intended use of laser, atherectomy or cryoplasty during index procedure;
• • 7. Sudden symptom onset, acute vessel occlusion, or acute or subacute thrombus in target vessel;
• • 8. History of stroke within 3 months;
• • 9. History of myocardial infarction, thrombolysis or angina within 2 weeks of enrollment;
• • 10. Participation in an investigational drug or another investigational device study until this study's primary endpoint is reached or previous enrollment in this study;
• • 11. 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;
• • 12. Target vessel and/or lesion involves a previously placed stent.