Clinical Trials Logo
  1. Home
  2. Atherosclerosis Obliterans
  3. NCT05473884

Lesion Preparation in Femoropopliteal Artery Occlusion Disease — CIVILIAN  

In-stent Restenosis Clinical Trial

Official title:
CIVILIAN Study in Femoropopliteal Artery Occlusion Disease

Clinical Trial Summary

Peripheral arterial disease (PAD) carries a significant global health burden, and can limit functional capacity and quality of life. Percutaneous transluminal angioplasty (PTA) for PAD is often associated with suboptimal outcomes due to complications following balloon inflation related to vessel trauma and flow limiting dissections that may require bailout stenting. Different strategies and techniques to enhance both acute and longer-term outcomes with drug-coated balloons (DCB) are needed. This is a national, prospective, multi-center, non-randomized, real-world study to evaluate the safety and efficacy of multiple vessel preparation strategies combined with drug-coating balloon (DCB) in Femoropopliteal Artery (F-PA) lesions.

Clinical Trial Description

Femoropopliteal artery occlusive disease is a common type of peripheral arterial disease (PAD). Hitherto, endovascular treatment has been testified and advocated as the first-line treatment of femoropopliteal occlusive disease. However, the in-stent restenosis has been a major limitation of well long-term patency rate in this segment due to physiological and geometrical issues. The concept "leave nothing behind" is proposed, and some vessel preparation methods and devices, such as directional atherectomy, rotational atherectomy, laser atherectomy are developed. This is a national, prospective, multi-center, non-randomized study to evaluate the safety and efficacy of multiple vessel preparation strategies combined with drug-coating balloon (DCB) in Femoropopliteal Artery (F-PA) lesions. A total of 1000 patients will be included in approximately 8 sites. The study is designed to demonstrate the inferiority of different vessel preparation strategies in various fields under long-term follow-up. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05473884
Study type Observational [Patient Registry]
Source Shanghai Pudong Hospital
Contact Bo Yu, M.D.
Phone 18918922698
Email paul.yubo@gmail.com
Status Recruiting
Phase
Start date June 1, 2022
Completion date May 31, 2024
View Details
See also
  Status Clinical Trial Phase
Completed NCT00341562 - Genomics of In-Stent Restenosis N/A
Completed NCT05509296 - Compare the Effectiveness and Safety of Two Different Kinds of Cutting Balloon in Coronary Artery Disease N/A
Not yet recruiting NCT06090890 - Anti-inflammatory Therapy for Recurrent In-stent Restenosis Phase 4
Active, not recruiting NCT00998439 - Treatment of Drug-eluting Stent (DES) In-Stent Restenosis With SeQuent® Please Paclitaxel Eluting Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Phase 2
Active, not recruiting NCT05731700 - CVT-ISR First in Human Trial for Coronary In-Stent Restenosis N/A
Completed NCT03260517 - The PREVAIL Study N/A
Not yet recruiting NCT03588962 - Metal Allergy In-Stent Restenosis Study N/A
Completed NCT00393315 - P E P C A D II, The Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease to Treat In-Stent Restenoses Phase 2
Recruiting NCT03874481 - The Effect of Sleep Quality on Coronary Artery Disease and In Stent Restenosis
Active, not recruiting NCT01127958 - DARE-trial: A Trial Studying the Effect of the SeQuent Please Drug-eluting Balloon Compared to the Xience Prime Drug-eluting Stent for the Treatment of Stenosis of an Earlier Implanted Stent. N/A
Active, not recruiting NCT04647253 - A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) Phase 3
Active, not recruiting NCT03529006 - Absorb Bioresorbable Scaffold vs. Drug Coated Balloon for Treatment Of In-Stent-Restenosis N/A
Completed NCT00485030 - Diffuse Type In-Stent Restenosis After Drug-Eluting Stent Phase 4
Not yet recruiting NCT03809754 - Optical Coherence Tomography Guided Percutaneous Coronary Intervention for Drug-eluting In-stent Restenosis N/A
Completed NCT00916279 - PERVIDEO I Registry, The Lutonix Paclitaxel-Coated Balloon Catheter for the Treatment of Coronary In-Stent Restenosis Phase 1/Phase 2
Recruiting NCT01239940 - RIBS IV (Restenosis Intra-stent of Drug-eluting Stents: Paclitaxel-eluting Balloon vs Everolimus-eluting Stent) Phase 4
Active, not recruiting NCT01239953 - RIBS V (Restenosis Intra-stent of Bare Metal Stents: Paclitaxel-eluting Balloon vs Everolimus-eluting Stent) Phase 4
Not yet recruiting NCT06148441 - Role of Novel Biomarkers Associated With In-stent Restenosis After Percutaneous Coronary Intervention
Completed NCT05512832 - In-stent Restenosis and Pericoronary Fat Attenuation Index
Recruiting NCT03521843 - LDD in Treatment of Femoropopliteal ISR N/A