A Study of Below The Knee Arteries' Stenosis or Occlusion Treated With LEGFLOW OTW

NCT02962232 | Unknown

• 1 other identifier: LEGFLOW-2015-02
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 19

Brief Summary

To evaluate the safety and efficacy of the Paclitaxel Releasing Peripheral Balloon Dilatation Catheter (LEGFLOW) compared to the PTA catheter (AMPHIRION DEEP) in treatment of stenosis or occlusion in below the knee artery.

Conditions

Peripheral Artery Disease

Keywords

drug eluting balloon; arterial vasculature below the knee

Outcome Measures

Primary Outcomes (1)

• Target lesion restenosis determined by CTA

  Restenosis defined as within the ± 5mm range beyond proximal and / or distal of target lesion, the lumen loss is greater than 50% of the reference vessel lumen diameter (RVD) follow-up by CTA. Target lesion revascularization (TLR): clinical symptoms of peripheral arterial disease recurrence or worsening, and any target lesion re-intervention caused by diameter stenosis ≥50% (confirmed by Doppler ultrasound, DSA or CT angiography).

  6 month post procedure

Secondary Outcomes (9)

• device success rate

  at 0-30 days

• operation success rate

  at 0-30 days

• clinical success rate

  at 0-30 days

• change of the Rutherford score

  in day 0-30, 6th month, 12th month post operation

• change of the life equality by EQ5D

  in day 0-30, 6th month, 12th month post operation compares to baseline

Study Arms (2)

LEGFLOW OTW group

EXPERIMENTAL

in the LEGFLOW OTW group the subject will be treated by the Paclitaxel Releasing Peripheral Balloon Dilatation Catheter (LEGFLOW)

Device: Paclitaxel Releasing Peripheral Balloon Dilatation Catheter

AMPHIRION DEEP group

ACTIVE COMPARATOR

in the AMPHIRION DEEP group the subject will be treated by PTA catheter (AMPHIRION DEEP)

Device: PTA catheter

Interventions

Paclitaxel Releasing Peripheral Balloon Dilatation Catheter DEVICE

treatment group

Also known as: LEGFLOW OTW

LEGFLOW OTW group

PTA catheter DEVICE

control group

Also known as: AMPHIRION DEEP

AMPHIRION DEEP group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age from 18 to 85 years (include 18 and 85 year);
• critical limb ischemia subjects (Rutherford classification from 3 to 6)
• expective survival more than 1 year;
• can understand the study objective, self willing enrolls and sign the informed consent, and accept scheduled followed up at the specific time.
• Angiographic inclusive criteria:
• reference vessel diameter 2.0-3.5mm;
• stenosis or occlusion in arterial vasculature below the knee shall have distal outflow;
• target lesion stenosis ≥70% or occlusion, length ≤270mm;
• if subject has ipsilateral / contralateral iliac lesions, the iliac lesion shall meet all the following criteria:
• iliac lesion or occlusion length ≤100mm and
• shall be treated earlier than the target lesion and
• shall be treated successfully. the successful treatment standard: 1) residual stenosis \<30%; 2) without flow limiting dissection 3) without thrombosis, embolism or any other serious adverse events

You may not qualify if:

• subjects currently participate in other drugs or medical devices clinical study and have not reach the primary endpoint;
• childbearing aged women whose pregnancy test before intervention operation is not negative, and lactating mothers;
• subjects with renal function insufficiency (serum creatinine\> 2.5mg / dL or in renal dialysis);
• subjects have known be allergy or contraindication to the contrast agent, paclitaxel, heparin, antiplatelet, anticoagulant or thrombolytic agents;
• subjects plan to a major amputation (over metatarsal level);
• stroke subjects within 3 months or stroke subjects with severe hemiplegia and aphasia associated sequelaes over 3 months before the intervention operation;
• subjects with acute myocardial infarction, thrombolytic therapy or angina within 30 days before the intervention operation;
• subjects whose target lesion limb have gangrene (the gangrene range over the metatarsophalangeal joint);
• target lesion is a stenosis or occlusion that have prior been treated by scaffold implantation, DEB, ordinary balloon catheter or bypass graft;
• lesions and /or occlusion locate or extend to popliteal artery or below ankle joint;
• subjects requiring be intervention in bilateral lower limb;
• the stenosis lesion of ipsilateral femoral artery or ipsilateral popliteal artery have a diameter stenosis ≥50% untreated before the intervention operation;
• ipsilateral femoral artery or ipsilateral popliteal artery has single or adjacent lesion length ≥15cm, or ipsilateral femoral artery or ipsilateral popliteal artery has multiple lesion and one of these multiple lesion length ≥10cm or occlusion;
• \- adjacent lesion: 1) interval no more than 30 mm, 2) can be treated as a single lesion;
• \- multiple lesion: 1) interval no more than 30 mm, 2) need to be treated as multiple lesion;

Sponsors & Collaborators

• ZhuHai Cardionovum Medical Device Co., Ltd.: lead

Study Sites (19)

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

RECRUITING

Hainan General Hospital

Haikou, Hainan, China

RECRUITING

Hebei General Hospital

Shijiazhuang, Hebei, China

RECRUITING

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

RECRUITING

Xiangya Hospital Central South University

Changsha, Hunan, China

NOT YET RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, China

RECRUITING

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

NOT YET RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, China

RECRUITING

Beijing Anzhen Hospital Capital Medical University

Beijing, China

RECRUITING

Beijing Chao-Yang Hospital

Beijing, China

RECRUITING

Beijing Frendship Hospital, Capital Medical University

Beijing, China

RECRUITING

Beijing Hospital

Beijing, China

RECRUITING

Beijing Shijitan Hospital, Capital Medical University

Beijing, China

RECRUITING

Chinese PLA General Hospital

Beijing, China

RECRUITING

Fuwai Hospital, Chinese Accadamy of Medical Sciences

Beijing, China

RECRUITING

Renji Hospital Shanghai Jiaotong University School of Medicine

Shanghai, China

NOT YET RECRUITING

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

Shanghai, China

RECRUITING

Tianjing Medical University General Hospital

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Chen zhong, professor

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chen zhong, professor

CONTACT

chenzhong8658@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 11, 2016
• Study Start: November 1, 2016
• Primary Completion: June 1, 2020
• Study Completion: December 1, 2020
• Last Updated: November 29, 2018

Record last verified: 2018-11

Locations

CN (19)