NCT04885985

Brief Summary

The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the Acotec Litos\&Tulip Drug-coated Balloon catheters in the treatment of lesions in below-the-knee artery.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Dec 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress83%
Dec 2021Apr 2027

First Submitted

Initial submission to the registry

May 10, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 13, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

December 31, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Expected
Last Updated

August 1, 2024

Status Verified

July 1, 2024

Enrollment Period

2.6 years

First QC Date

May 10, 2021

Last Update Submit

July 30, 2024

Conditions

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Primary Patency

    Primary patency rate is defined as freedom from clinically-driven target lesion revascularisation (CD-TLR) , restenosis as determined by duplex ultrasound (DUS) or digital subtraction angiography (DSA) or major target limb amputation.

    6 month

Secondary Outcomes (8)

  • Major adverse event (MAE) rate

    30 days

  • Patency rate

    12 months,24 months,36 months,48 months ,60 months

  • Rate of major target limb amputation

    12 months,24 months,36 months,48 months ,60 months

  • Rate of All-cause mortality

    12 months,24 months,36 months,48 months ,60 months

  • Rate of clinically-driven target vessel revascularization (CD-TVR)

    12 months,24 months,36 months,48 months ,60 months

  • +3 more secondary outcomes

Study Arms (1)

DEB catheter

EXPERIMENTAL

Use DEB catheter to treat the stenosis or occlusion in below popliteal artery of experimental arm

Device: DEB catheter

Interventions

DEB catheterDEVICE

Trade name of DEB catheter: AcoArt Tulip (0.018") or AcoArt Litos (0.014")

DEB catheter

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Age ≥18 years old and ≤75 years old
  • \. Rutherford clinical category classification：3,4 or 5
  • \. Significant stenosis (≥70%) or occlusions of de-novo or restenotic lesion(s) located in below-the-knee arteries which distal bloodflow is patent.
  • \. Reference vessel diameter is between 2 mm and 4 mm
  • \. Subject has provided written informed consent prior to participation , understands the purpose of this trail and agrees to comply with all protocol-specified examinations and follow-up appointments.

You may not qualify if:

  • \. Plasma creatinine clearance rate \<30 mL/min
  • \. Acute vessel occlusion or acute thrombosis in target lesion
  • \. Planned amputation on the target limb
  • \. Subjects confined to bed that are completely non-ambulatory.
  • \. Thrombolytic therapy or surgical procedure on the target limb within 6 weeks prior to enrollment.
  • \. Life expectancy \< 5 year.
  • \. Cumulative length of 100% occluded target lesion(s)\>150 mm
  • \. In-stent restenosis within the target lesion, or the distance between the target lesions and the stent was less than 20 mm
  • \. History of stroke within 90 days prior to enrollment
  • \. Known allergy to contrast agents, antiplatelet, anticoagulant, or thrombolytic therapy
  • \. Uncorrectable bleeding diathesis
  • \. The lesion of the inflow pathway cannot be identified due to the complete occlusion of the P3 segment of the popliteal artery
  • \. Pregnant or breastfeeding female subjects
  • \. Ability to cross a guidewire through target lesion
  • \. Patients who have participated in clinical trials of other medical devices or drugs during the same period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chui Yang Liu Hospital affiliated to Tsinghua University

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • Zhuang Baixi

    Xiyuan Hospital of China Academy of Chinese Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhuang Baixi

CONTACT

010-62835122zhuangbaixi@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2021

First Posted

May 13, 2021

Study Start

December 31, 2021

Primary Completion

August 1, 2024

Study Completion (Estimated)

April 1, 2027

Last Updated

August 1, 2024

Record last verified: 2024-07

Locations

CN(1)