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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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 provisions, and has duly signed the Informed Consent Form (ICF);

• 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 prior to treatment with stents placement).

• 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;

• Female subjects 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.

Locations
Other Locations
China
Kaichuang Ye
RECRUITING
Shanghai
Minyi Yin
RECRUITING
Shanghai
Xiaobing Liu
RECRUITING
Shanghai
Contact Information
Primary
Kai'chuang Ye, MD, PhD
ykaichuang@163.com
+86 021-23271699-5591
Backup
Xinrui Yang, MD, PhD
cinder_13@126.com
+86 021-23271699-5591
Time Frame
Start Date: 2019-01-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 180
Treatments
Experimental: DCB for post-dilation
DCB was used for post-dilation after stent placement. The DCB for post-dilation in this study is Orchid 035 DCB Catheter.
Active_comparator: POBA for post-dilation
POBA was used for post-dilation after stent placement. POBA Catheter for post-dilation in this study can be Mustang, Dorado or others balloon catheters.
Sponsors
Leads: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

This content was sourced from clinicaltrials.gov