Lesion Preparation in Femoropopliteal Artery Occlusion Disease (CIVILIAN)

November 2, 2022 updated by: Bo Yu, MD, Shanghai Pudong Hospital

CIVILIAN Study in Femoropopliteal Artery Occlusion Disease

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 201200
        • Recruiting
        • Shanghai Pudong Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No

Description

General Inclusion Criteria:

  • Patient or patient's legal representative have been informed of the nature of the study, agrees to participate and has signed an Ethical Committee approved consent form
  • Patient has a score from 2 to 5 following Rutherford classification
  • Unilateral or bilateral F-P occlusive lesions (enrollment of one or both target limbs depend on operators)
  • Complete recanalization followed by POBA, Chocolate PTA, Scoring PTA, Shockwave PTA, SilverHawk, TurboHawk, Jetstream, Angiojet, Laser and Rotarex

Angiographic Inclusion Criteria:

  • TASC II-Type A/B/C/D
  • Iliac inflow interventions can be done at the discretion of the investigator with standard balloon Percutaneous Transluminal Angioplasty (PTA)-less than 50% residual stenosis
  • There is angiographic evidence of at least one-vessel-runoff (>10cm) to the foot

General Exclusion Criteria:

  • Projected for major amputation of target limb (above ankle joint)
  • Change to thrombectomy or bypass during operation
  • Patients for whom antiplatelet therapy, anticoagulants, medium contrast, or thrombolytic drugs are contraindicated
  • Patient has bleeding diathesis, coagulopathy, known hypercoagulable condition or refuses blood transfusion
  • female patient with childbearing potential not taking adequate contraceptives or currently breastfeeding.
  • Life expectancy of less than twelve months.
  • Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period.
  • Patient presenting one of the following comorbid conditions: hemodialysis, elevated creatine levels (> 2.5mg/dl), recent MI or ischemic stroke occurrence (both within 30 days).
  • Patient unwilling or unlikely to comply with Follow-Up schedule

Angiographic Exclusion Criteria:

  • Testified for acute F-P arterial embolization
  • Thromboangiitis obliterans
  • Failed for recanalization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
lesion preparation with POBA in femoropopliteal Artery occlusion
Patients with femoropopliteal artery occlusion were treated by plain old balloon angioplasty followed with DCB.
Device: conventional balloon
Lumen gain is achieved by plain old balloon angioplasty under working inflation pressure.
lesion preparation with debulking devices in femoropopliteal Artery occlusion
Patients with femoropopliteal artery occlusion were treated by other lesion preparation devices, like Chocolate balloon, Shockwave balloon, TurboHawk, Jetstream and Rotarex and then followed by DCB.
Device: lesion preparation devices
successful recanalization of femoropopliteal artery occlusion and then followed by lesion preparation devices and plain old balloon angioplasty
Other Names:
  • Chocolate balloon
  • Shockwave balloon
  • Rotarex
  • TurboHawk
  • Jetstream

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Freedom from TLR
Time Frame: within 12 months post-procedure
Percentage of participants with a 1-year TLR free survival
within 12 months post-procedure
Incidence of complications
Time Frame: immediately following procedure (day 30)
Procedure-related complications at day 30, defined as: procedure-related distal embolization, acute post-procedural target vessel thrombosis, bleeding, perforation, acute renal failure
immediately following procedure (day 30)
Major adverse event
Time Frame: within 12 months post-procedure
Major adverse events (MAE) rate at 1 year, defined as: Myocardial Infarction (MI), major amputation, all-cause mortality
within 12 months post-procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Technical Success
Time Frame: within 24 hours post-procedure
Technical success, defined as the ability to cross the target lesion with the device, set up antegrade blood flow and leave residual stenosis <30%
within 24 hours post-procedure
Incidence of dissection and types
Time Frame: immediately following vessel preparation
Dissection patterns according to the National Heart, Lung and Blood Institute classification system for the coronary artery. (Type A-F) (A) Type A has minor radiolucent areas, (B) type B is a linear dissection, (C) type C has contrast outside the lumen, (D) type D is a spiral dissection, (E) type E has persistent filling defects, and (F) type F is a total occlusion without distal antegrade flow
immediately following vessel preparation
Incidence of Bailout stenting
Time Frame: immediately following vessel preparation and DCB angioplasty
Bailout stenting, defined as stent implantation after vessel preparation and DCB including bare metal stents (BMS), covered stents and drug-eluting stents (DES)
immediately following vessel preparation and DCB angioplasty
Amputation Free Survival
Time Frame: within 12 months post-procedure
Percentage of participants with a 1-year amputation free survival
within 12 months post-procedure
Numbers of patients with Primary patency
Time Frame: within 3, 6, 12 months post-procedure
Primary patency rate at 6, 12, 24 months as determined by Duplex ultrasound at six months, defined as a target vessel with <50% diameter stenosis (systolic velocity ratio no greater than 2.4), without occurrence of target lesion revascularization between the index procedure and follow-up control
within 3, 6, 12 months post-procedure
Improvement of ABI
Time Frame: within 3, 6, 12 months post-procedure
Increase of Ankle-Brachial Index (ABI) at 12, 24 months, defined as: an increase in ABI compared to baseline
within 3, 6, 12 months post-procedure
Improvement of related symptoms
Time Frame: within 3, 6, 12 months post-procedure

related symptoms could be identified as Rutherford classification from level 1-6.

improvement in Rutherford classification compared to the pre-procedure Rutherford classification
within 3, 6, 12 months post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Pudong Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shanghai Zhongshan Hospital
RenJi Hospital
Huashan Hospital
Xuanwu Hospital, Beijing
First Affiliated Hospital of Zhejiang University
Second Affiliated Hospital of Soochow University
Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
Qingdao Hiser Medical Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2024

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 26, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Shanghai-CIVILIAN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings