Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT05616520
Status:
UNKNOWN
Last Update Posted:
2023-10-23
First Post:
2022-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Complex Femoropopliteal Artery Lesions Using Drug-coated PTA Balloon
Sponsor:
Xuanwu Hospital, Beijing
Organization:
Study Overview
Official Title:
Clinical Efficacy for the Treatment of Complex Femoropopliteal Artery Lesions Using Drug-coated PTA Balloon：a Real-world Registry Study(CARPLAY-DCB Study)
Status:
UNKNOWN
Status Verified Date:
2023-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Although DCBs had been widely applicable after registration, there are still lack of clinical data and evidence in the real world condition of Chinese population. This data collection aims to perform regularly clinical follow up to guide the standardized diagnosis and treatment of patients post-operatively, in order to achieve the maximum clinical benefits of these patients, as well as improve the development of the field of peripheral artery disease treated by drug-coated balloon.
Detailed Description:
Historically, symptomatic PAD was treated with surgical bypass; however endovascular treatment is now the first line treatment when medical therapy fails. Several endovascular treatment options exist including percutaneous transluminal angioplasty (PTA), stenting with bare metal or drug-eluting stents (DES), cutting balloons, atherectomy, laser debulking. Moreover, drug-coated balloon（DCB）has emerged as a potential treatment option, combining acute restoration of vessel patency by balloon dilatation with long term maintenance of such patency by the anti-proliferative drug delivered by the balloon surface. Results from numerous clinical studies with paclitaxel coated balloons have been reported for the safety and efficacy for peripheral artery diseases.
Besides Medtronic IN.PACT Admiral, other DCBs approved for marketing in Chinese Mainland include Acoart (Acotec, China), Reewarm ® PTX (endovastec, China), Ultrafree (ZYLOX, China). Although DCBs had been widely applicable after registration, there are still lack of clinical data and evidence in the real world condition of Chinese population. Therefore, the data collection can also further expand and understand the experience of using DCB in a real world patient population in China, especially for the surveillance of safety events, in order to ensure the long-term application safety in Chinese population. Moreover, this data collection aims to perform regularly clinical follow up to guide the standardized diagnosis and treatment of patients post-operatively, in order to achieve the maximum clinical benefits of these patients, as well as improve the development of the field of peripheral artery disease treated by drug-coated balloon.
Besides Medtronic IN.PACT Admiral, other DCBs approved for marketing in Chinese Mainland include Acoart (Acotec, China), Reewarm ® PTX (endovastec, China), Ultrafree (ZYLOX, China). Although DCBs had been widely applicable after registration, there are still lack of clinical data and evidence in the real world condition of Chinese population. Therefore, the data collection can also further expand and understand the experience of using DCB in a real world patient population in China, especially for the surveillance of safety events, in order to ensure the long-term application safety in Chinese population. Moreover, this data collection aims to perform regularly clinical follow up to guide the standardized diagnosis and treatment of patients post-operatively, in order to achieve the maximum clinical benefits of these patients, as well as improve the development of the field of peripheral artery disease treated by drug-coated balloon.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: