NCT04982367

Brief Summary

A prospective randomized trial designed to compare the efficacy and safety of Sirolimus coated balloon (SCB) versus paclitaxel coated balloon (DCB) in the treatment of femoropopliteal artery stenosis

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
166

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 29, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

December 8, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

2.6 years

First QC Date

July 21, 2021

Last Update Submit

October 16, 2023

Conditions

Peripheral Artery Disease

Keywords

Drug eluting balloon catheterPeripheral Artery Disease

Outcome Measures

Primary Outcomes (1)

  • The primary patency rate of target lesion at 12 months post-procedure

    Defined as freedom from clinically driven target lesion revascularization (CD-TLR) and binary restenosis (restenosis defined as duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≥2.4)

    12 months post-procedure

Secondary Outcomes (5)

  • Rate of device success

    immediate post-procedure

  • Rate of clinically driven target lesion revascularization (CD-TLR) at 12 months post-procedure

    12 months post-procedure

  • The change of Rutherford class from baseline

    12 months post-procedure

  • The change of ankle-brachial index (ABI) from baseline

    12 months post-procedure

  • Rate of composite safety endpoint

    30 days post-procedure

Study Arms (2)

Sirolimus-eluting balloon angioplasty

EXPERIMENTAL

Using Sirolimus Coated Balloon Catheter in the treatment of stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery

Device: Sirolimus-eluting balloon catheter

Paclitaxel-eluting balloon angioplasty

ACTIVE COMPARATOR

Using Paclitaxel Coated Balloon Catheter in the treatment of stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery

Device: Paclitaxel-eluting balloon catheter

Interventions

Sirolimus-eluting balloon catheterDEVICE

Sirolimus-eluting balloon catheter designed and produced by Acotec

Also known as: Sirolimus coated balloon catheter
Sirolimus-eluting balloon angioplasty
Paclitaxel-eluting balloon catheterDEVICE

Paclitaxel-eluting balloon catheter (trade name:DHALIA)

Also known as: Paclitaxel coated balloon catheter
Paclitaxel-eluting balloon angioplasty

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years old and ≤80 years old
  • Had lower extremity arterial occlusive diseases, and Rutherford classification is 2-5
  • SFA and/or popliteal artery had severe stenosis (stenosis degree ≥70%) or occlusion.
  • The length of target lesion less than 20 cm
  • Subject (or legal guardian) understands the study requirements and procedures and provides written Informed Consent before any study tests or procedures are performed

You may not qualify if:

  • The plasma creatinine level is higher than 150 umol/L
  • Thrombolysis or thrombectomy is required
  • There are more than 2 lesion need to treat in the target vessel.
  • The patient had underwent lower-limb arterial surgery or thrombolysis on the target limb within 6 weeks.
  • The target lesion had residual stenosis\>30% or flow-limit dissection after pre-dilatation.
  • The patient had outflow less than 1 vessel
  • The lesion located in a stent.
  • Patient has a known allergy to aspirin, clopidogrel, heparin, paclitaxel, sirolimus or contrast medium that cannot be adequately pre-medicated.
  • Women who are pregnant or breast-feeding.
  • The subjects have participated in other drug property studies or device studies that have not yet completed the main end point.
  • Patient has life expectancy of less than 12 months.
  • The investigator think the patient is not suitable for participation in the clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100039, China

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • Guo Wei, MD

    Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guo Wei, MD

CONTACT

010-66887329pla301dml@vip.sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2021

First Posted

July 29, 2021

Study Start

December 8, 2021

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

October 18, 2023

Record last verified: 2023-10

Locations

CN(1)