NCT05894863

Brief Summary

This study aims to evaluate the effectiveness and safety of the Smart flex stent system in treating long femoropopliteal native lesions.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started May 2023

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 Progress82%
May 2023Jan 2027

First Submitted

Initial submission to the registry

May 31, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

May 31, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 8, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2027

Expected
Last Updated

June 8, 2023

Status Verified

May 1, 2023

Enrollment Period

2.6 years

First QC Date

May 31, 2023

Last Update Submit

May 31, 2023

Conditions

Peripheral Arterial Disease

Keywords

Femoropopliteal lesionsPatency

Outcome Measures

Primary Outcomes (2)

  • Primary patency

    Primary patency is freedom from clinically directed target lesion revascularization (CD-TLR) and from Duplex ultrasound-derived binary restenosis (defined as peak systolic velocity ratio ≧2.5).

    12-month

  • Freedom of major adverse events (MAEs)

    Major adverse events(MAEs) is defined as index limb amputation above the ankle, clinically directed target lesion revascularization(CD-TLR), or all-cause death.

    12-month

Secondary Outcomes (6)

  • Acute procedure success

    72-hour within procedure

  • Primary patency

    24-month

  • Freedom from clinically directed target lesion revascularization

    24-month

  • Freedom of major adverse events (MAEs)

    24-month

  • Primary sustained clinical improvement

    24-month

  • +1 more secondary outcomes

Study Arms (1)

Smart flex stent group

EXPERIMENTAL

Smart flex stent will be used for patients with femoropopliteal lesions receiving endovascular treatment.

Device: Smart flex stent

Interventions

Smart flex stentDEVICE

Smart flex stent will be used for femoropopliteal occlusive lesions.

Smart flex stent group

Eligibility Criteria

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

You may qualify if:

  • The patient presented a score from 2 to 5 following Rutherford classification
  • The patient is willing to comply with specified follow-up evaluations at the specified times
  • The patient is \>18 years old
  • Patient understands the nature of the procedure and provides written informed consent before enrolment in the study
  • The patient has a projected life expectancy of at least 24 months
  • Before enrolment, the guidewire has crossed the target lesion
  • Target lesion length ≧150mm by angiographic estimation
  • Stenosis \> 50% or occlusion in the femoropopliteal artery
  • There is angiographic evidence of patent distal popliteal artery and at least one distal runoff to the foot

You may not qualify if:

  • Previous bypass surgery or stenting in the target vessel
  • Patients who exhibit acute intraluminal thrombus at the target lesion vessel
  • Patients with known hypersensitivity or contraindication to any of the following medications: Nitinol-titanium, antiplatelet therapy, anticoagulants, or thrombolytics therapy
  • Pregnant women or Female patients with potential childbearing
  • Use of thrombectomy, atherectomy, or laser devices during the procedure
  • Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion
  • The patient is currently participating in another investigational drug or device study that has not reached the primary endpoint.
  • Significant renal dysfunction (Serum creatinine \>2.0mg/dl)
  • Patient with Known allergy to contrast media

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • Meng Ye, M.D.

    Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ni Qihong, M.D.

CONTACT

+8615801900772niqihong1989@163.com

Study Design

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

Study Record Dates

First Submitted

May 31, 2023

First Posted

June 8, 2023

Study Start

May 31, 2023

Primary Completion

January 2, 2026

Study Completion (Estimated)

January 2, 2027

Last Updated

June 8, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)