DCB Versus Primary Selective Stenting in TASC C/D Femoropopliteal Artery Disease

Safety Issues Clinical Trial

Official title:

Paclitaxel Coated Balloon Angioplasty Versus Primary Selective Stenting in the Treatment of TASC C/D Chronic Femoropopliteal Artery Occlusive Disease: A Multicenter Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05517291
• Other study ID #: PASS
• Status: Recruiting
• Phase: N/A
• Start date: September 18, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: December 2022
• Source: Peking Union Medical College Hospital
• Contact: Leng Ni, MD
• Phone: 86-1069152501
• Email: nileng[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to compare the mid- and long-term outcomes between paclitaxel-coated balloon and primary selective stenting in the treatment of TASC C/D femoropopliteal artery occlusive disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Subject age 18-85yrs.
• Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved consent form.
• Subject understands the duration of the study, agrees to attend follow-up visits, and agrees to complete the required testing.
• Rutherford category 2-5.
• Subject has a de novo TASC C/D femoropopliteal artery lesions which does not exceed to the segment P1 of popliteal artery.
• The total length of target lesion =30cm.
• Reference vessel diameter >4 mm and <6.5 mm by visual assessment.
• Patent inflow artery with stenosis <30% and at least 1 infrapopliteal artery to the ankle (<50% diameter stenosis).
• A guidewire has successfully traversed the target treatment segment.

Exclusion Criteria:

• Acute thrombus in the target vessels.
• Vessel stenosis or occlusion due to Buerger's disease or autoimmune arteritis.
• Subject received prior stents implantation with in-stent restenosis or occlusion.
• Reintervention of the target lesion <90 days before the study procedure.
• Acquired thrombophilia or uncontrolled hypercoagulation states.
• Life expectancy <12 months.
• Severe renal(SCr=2.5 mg/dl)or hemodialysis dependence.
• Pregnancy, suspected pregnancy, or breastfeeding during study period.
• Contraindication to contrast media or any study-required medication (antiplatelet, anticoagulant, or thrombolytic agents, etc.).
• Hypersensitivity to nitinol and/or paclitaxel.

Related Conditions & MeSH terms

• Efficacy, Self
• Safety Issues

Intervention

Device:
• paclitaxel-coated balloon angioplasty or bare mental stents implantation
paticipants who enrolled in this study will received paclitaxel-coated balloon angioplasty plus bailout stenting or primary bare mental stents implantation randomly

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1-year primary patency rate		1 year
Secondary	clinical-driven target lesion revascularization		1, 2 and 3 years