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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: Chocolate balloon

• Study Type: Observational
• Enrollment (Estimated): 254

Contacts and Locations

Study Locations

• China
  • None Selected
    • Beijing, None Selected, China, 100053
      • Recruiting
      • Xuanwu Hospital
      • Contact: Zhu Tong; Phone Number: 13522419980; Email: tongzhuxw@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

patients with femoropopliteal atherosclerotic occlusive disease

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chocolate balloon	Device: Chocolate balloon; Vascular preparation with chocolate balloons prior to drug-coated balloon angioplasty
Conventional ballon	Device: Chocolate balloon; Vascular preparation with chocolate balloons prior to drug-coated balloon angioplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 30, 2023
• First Submitted That Met QC Criteria: May 30, 2023
• First Posted (Actual): June 8, 2023

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: July 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Peripheral artery disease; Drug-coated balloon; Popliteal artery; Femoral artery; Chocolate percutaneous transluminal angioplasty balloon
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: Chocolate-FP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes