Clinical Trials Logo
  1. Home
  2. Peripheral Arterial Disease
  3. NCT05894460
  4. Details
NCT05894460 Clinical Trial

Constrained Balloon Combined With Drug-coated Balloon Angioplasty for Femoropopliteal Lesion

Peripheral Arterial Disease Clinical Trial

Official title:
Constrained Balloon Combined With Drug-coated Balloon Angioplasty for Femoropopliteal Lesion: a Single-centre, Prospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05894460
Other study ID # Chocolate-FP
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 27, 2023
Est. completion date December 31, 2024

Study information
Verified date May 2023
Source Xuanwu Hospital, Beijing
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will assess the safety and efficacy of Chocolate balloons as a combination with drug-coated balloons in the treatment of popliteal artery lesions in lower limb atherosclerotic occlusive disease and will compare them with conventional balloons.

Recruitment information / eligibility
Status Recruiting
Enrollment 254
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Rutherford classification of 2-6 in patients with femoropopliteal atherosclerotic occlusive disease; - primary cases with no previous surgical treatment of the target lesion; - presence of at least one vessel with patency in the distal outflow tract; - survival >1 year. Exclusion Criteria: - planned stenting; - presence of flow-limiting dissection prior to application of Chocolate balloon and conventional balloon dilation of the target lesion; - combination of severe organ dysfunction of the heart, lungs and brain that cannot tolerate the procedure; - allergy to contrast agents, anaesthetic drugs, anticoagulants and anti-platelet drugs; - ineffective recanalization attempts; - lesions within or adjacent to the aneurysm, or the presence of a popliteal aneurysm.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Chocolate balloon
Vascular preparation with chocolate balloons prior to drug-coated balloon angioplasty

Locations
Country Name City State
China Xuanwu Hospital Beijing None Selected

Sponsors (1)
Lead Sponsor Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Primary patency No occlusion or restenosis (>50%) of the target vessel in the treated segment during follow-up and no further intervention is required. 12 months
See also
  Status Clinical Trial Phase
Recruiting NCT06032065 - Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD) Phase 3
Active, not recruiting NCT03987061 - MOTIV Bioresorbable Scaffold in BTK Artery Disease N/A
Recruiting NCT03506633 - Impacts of Mitochondrial-targeted Antioxidant on Peripheral Artery Disease Patients N/A
Active, not recruiting NCT03506646 - Dietary Nitrate Supplementation and Thermoregulation N/A
Active, not recruiting NCT04677725 - NEtwork to Control ATherothrombosis (NEAT Registry)
Recruiting NCT05961943 - RESPONSE-2-PAD to Reduce Sedentary Time in Peripheral Arterial Disease Patients N/A
Recruiting NCT06047002 - Personalised Antiplatelet Therapy for Patients With Symptomatic Peripheral Arterial Disease
Completed NCT03185052 - Feasibility of Outpatient Care After Manual Compression in Patients Treated for Peripheral Arterial Disease by Endovascular Technique With 5F Sheath Femoral Approach N/A
Recruiting NCT05992896 - A Study of Loco-Regional Liposomal Bupivacaine Injection Phase 4
Completed NCT04635501 - AbsorbaSeal (ABS 5.6.7) Vascular Closure Device Trial N/A
Recruiting NCT04584632 - The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery N/A
Withdrawn NCT03994185 - The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease N/A
Withdrawn NCT03538392 - Serranator® Alto Post Market Clinical Follow Up (PMCF) Study
Recruiting NCT02915796 - Autologous CD133(+) Cells as an Adjuvant to Below the Knee Percutaneous Transluminal Angioplasty Phase 1
Active, not recruiting NCT02900924 - Observational Study to Evaluate the BioMimics 3D Stent System: MIMICS-3D
Completed NCT02901847 - To Evaluate the Introduction of a Public Health Approach to Peripheral Arterial Disease (PAD) Using National Centre for Sport and Exercise Medicine Facilities. N/A
Not yet recruiting NCT02455726 - Magnesium Oral Supplementation to Reduce Pain Inpatients With Severe Peripheral Arterial Occlusive Disease N/A
Not yet recruiting NCT02387450 - Reduced Cardiovascular Morbi-mortality by Sildenafil in Patients With Arterial Claudication Phase 2/Phase 3
Withdrawn NCT02126540 - Trial of Pantheris System, an Atherectomy Device That Provides Imaging While Removing Plaque in Lower Extremity Arteries N/A
Completed NCT02022423 - Physical Activity Daily - An Internet-Based Walking Program for Patients With Peripheral Arterial Disease N/A