Comparing drug-coated balloons and plain balloons for stenting in leg arteries

A Prospective, Single Center, Case-cohort Study Using the Orchid Drug Coated Balloon for Post-Dilatation of the Stent for Treatment of Long Lesions in Femoropopliteal Arteries

This study is testing whether using drug-coated balloons works better than regular balloons for treating blocked leg arteries in certain patients.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University (Academic / other)
• Locations: 3 sites (Shanghai, Shanghai Municipality and 2 other locations)
• Trial ID: NCT03791970 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness and safety of using Orchid 035 Drug Coated Balloons (DCB) versus Plain Old Balloon Angioplasty (POBA) for post-dilatation in patients with long femoropopliteal chronic total occlusions. It is a prospective, single-center, case-cohort study where patients will undergo stent angioplasty followed by either DCB or POBA. Data will be collected on patient demographics, medical history, and clinical assessments, including angiographic measurements during the procedure. The study will focus on patients with specific criteria related to their vascular health and the characteristics of their occlusions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with chronic limb ischemia and long occlusions in their femoropopliteal arteries.

Not a fit: Patients with significant outflow disease or those unable to undergo the required procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment outcomes for patients with peripheral artery disease by identifying the more effective post-dilatation method.

How similar studies have performed: Previous studies have shown promising results with drug-coated balloons in similar vascular interventions, suggesting potential for success in this approach.

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.

Where this trial is running

Shanghai, Shanghai Municipality and 2 other locations

• Kaichuang Ye — Shanghai, Shanghai Municipality, China (Recruiting)
• Minyi Yin — Shanghai, Shanghai Municipality, China (Recruiting)
• Xiaobing Liu — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Kai'chuang Ye, MD, PhD

Conditions Peripheral Artery Disease