NCT02965677

Brief Summary

To evaluate the safety and efficacy of the Paclitaxel Releasing Peripheral Balloon Dilatation Catheter (LEGFLOW) compared with the standard balloon (Admiral Xtreme) for the treatment of stenosis or occlusions in femoral popliteal artery.

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
172

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

13 active sites

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

November 7, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 17, 2016

Completed
14 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

November 29, 2018

Status Verified

November 1, 2018

Enrollment Period

4 years

First QC Date

November 7, 2016

Last Update Submit

November 27, 2018

Conditions

Peripheral Arterial Disease

Keywords

drug eluting balloonFemoral Popliteal Artery

Outcome Measures

Primary Outcomes (1)

  • clinically driven target lesion revascularization (CD-TLR)

    12 month post procedure

Secondary Outcomes (15)

  • Procedural Success

    at 0-30 days

  • Device Success

    at 0-30 days

  • Clinical Success

    at 0-30 days

  • Change in Rutherford classification measured

    at 0-30 days, 6 months and 12 months post procedure

  • Change in ABI measure

    at 0-30 days, 6 months and 12 months post procedure

  • +10 more secondary outcomes

Study Arms (2)

LEGFLOW OTW group

EXPERIMENTAL

in this group subject will be treated by Paclitaxel Releasing Peripheral Balloon Dilatation Catheter (LEGFLOW) and followed up

Device: Paclitaxel Releasing Peripheral Balloon Dilatation Catheter

Admiral Xtreme

ACTIVE COMPARATOR

in this group subject will be treated by Peripheral Balloon Dilatation Catheter (Admiral Xtreme) and followed up

Device: Peripheral Balloon Dilatation Catheter

Interventions

Paclitaxel Releasing Peripheral Balloon Dilatation CatheterDEVICE

in this group the subject will be treated by Paclitaxel Eluting Balloon Dilatation Catheter

Also known as: LEGFLOW OTW
LEGFLOW OTW group
Peripheral Balloon Dilatation CatheterDEVICE

in this group the subject will be treated by Paclitaxel Eluting Balloon Dilatation Catheter

Also known as: Admiral Xtreme
Admiral Xtreme

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years and ≤ 85 years.
  • De novo or restenotic lesions in the femoral popliteal artery due to atherosclerosis, which located in the superficial femoral artery and/or proximal popliteal artery (arterial segment starting at least 1cm beyond the common femoral artery bifurcation to the distal P1 segment of the popliteal artery at the level of the proximal edge of the patella). And the patients are suitable for endovascular therapy with LEGFLOW OTW or Admiral Xtreme.
  • Rutherford class 2 to 5.
  • Target lesion length ≤ 200mm.
  • Target lesion stenosis ≥ 70% or total occlusion, and it can be passed with common manipulation.
  • Reference vessel diameter ≥ 4mm and ≤ 8mm by visual estimate.
  • Target lesion consists of a single of de novo or restenotic lesion, or a adjacent lesion or a combination lesion or multiple lesion which meets the following criteria:
  • adjacent lesion: (1) lesion space ≤ 30mm; (2) total lesion length (include lesion space) ≤ 200mm; (3) can be treated as a single lesion.
  • Combination lesion: combination lesion is defined as not a chronic total occlusion (CTO), but may include a part of total occlusion (100% stenosis). The total lesion length ≤ 200mm.
  • Multiple lesion: (1) lesion space \> 30mm; (2) total lesion length (include lesion space) ≤ 200mm; (3) can be treated as multiple lesions.
  • Angiographic evidence of adequate distal run-off to the foot (at least one native calf vessel is patent, defined as \< 50% diameter stenosis), whether or not this outfolw was re-established by previous intervention.
  • If subject has ipsilateral/contralateral iliac disease that requires treatment during the procedure, the iliac lesions must meet all the following criteria:
  • Iliac lesion or occlusion is ≤ 100mm in length;
  • must be treated before the target lesion (superficial femoral artery/proximal popliteal artery).
  • must be successfully treated before target lesion treatment; success is defined as: (1) residual stenosis \< 30%; (2) free of dissection which can limit blood flow; (3) no occurrence of thrombus, embolization, or other SAE.
  • +2 more criteria

You may not qualify if:

  • Women of childbearing age with negative pregnancy test before procedure, and breastfeeding women.
  • Stroke or STEMI within 30 days prior to the procedure.
  • Either local or systemic thrombolytic therapy within 6 weeks prior to the procedure.
  • Any major surgical operation (operation class ≥ 3) or interventional therapy within 30 days prior to the procedure.
  • Any major selective surgical operation (operation class ≥ 3) or interventional therapy within 30 days prior to the procedure.
  • Restenotic lesions after DCB or bypass surgery.
  • Target limb has been previously treated with bypass surgery.
  • Guidewire must be passed through from the distal part of limb.
  • Known allergies or sensitivities to contrast agent, paclitaxel, anti-platelet, anticoagulants or thrombolytic drugs.
  • Known allergies or sensitivities to heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II.
  • Aneurysm located at the target vessel.
  • Acute or sub-acute thrombosis in the target vessel.
  • Angiographic evidence of severe calcification (defined as dense circumferential calcification that makes the target lesion non-dilatable and/or calcificatin that is present on both sides of the vessel wall and that extends more than 5 cntinuous centimeters in length within the target lesion prior to contrast injection or digital subtraction angiography).
  • The bilateral lower limb must be treated in one procedure.
  • Uncorrected bleeding disorder.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

RECRUITING

Hainan General Hospital

Haikou, Hainan, China

RECRUITING

The First hospital of Hebei Medical University

Shijiazhuang, Hebei, China

NOT YET RECRUITING

Xiangya Hospital Central South University

Changsha, Hunan, China

NOT YET RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

RECRUITING

Beijing Anzhen Hospital, Capital Medical University

Beijing, China

NOT YET RECRUITING

Beijing Chao-yang Hospital, Capital Medical University

Beijing, China

RECRUITING

Beijing Hospital

Beijing, China

RECRUITING

Beijing Shijitan Hospital, Capital Medical University

Beijing, China

RECRUITING

Fuwai Hospital, Chinese Accadamy of Medical Sciences

Beijing, China

RECRUITING

Longhua Hospital Shanghai University of Tranditional Chinese Medicine

Shanghai, China

ENROLLING BY INVITATION

Shanghai Ninth people's Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

RECRUITING

Tianjin Medical University General Hospital

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • Guo Wei, professor

    Chinese PLA Genral Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guo Wei, professor

CONTACT

010-66938349pla301dml@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

November 7, 2016

First Posted

November 17, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2020

Study Completion

June 1, 2021

Last Updated

November 29, 2018

Record last verified: 2018-11

Locations

CN(13)