NCT03267056

Brief Summary

The registry is a prospective, multicenter, single arm post-market real-world registry in China assessing the clinical use, safety and outcomes of the Orchid 035 DCB Catheter in the Superficial Femoral Artery (SFA) and Popliteal Arteries (PA).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

10 active sites

Status
completed

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

August 24, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 30, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

January 19, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

August 19, 2020

Status Verified

April 1, 2020

Enrollment Period

2.3 years

First QC Date

August 24, 2017

Last Update Submit

August 18, 2020

Conditions

Peripheral Artery Disease

Keywords

drug-coated balloon

Outcome Measures

Primary Outcomes (1)

  • Primary patency of target lesion.

    The primary efficacy end point was primary patency at 12 months following the index procedure, defined as freedom from clinically driven target lesion revascularization and restenosis as determined by a duplex ultrasonography-derived peak systolic velocity ratio of ≤2.4

    12 months

Secondary Outcomes (4)

  • target lesion revascularization,target lesion revascularization is defined as any reintervention of artery bypass graft surgery involving the target lesion

    6 months, 12 months

  • improvment in Rutherford stage

    6 months, 12 months

  • change in ankle brachial index(ABI)

    12 months

  • Device success during the operation

    during the operation

Study Arms (1)

DCB arm

drug eluting balloon catheter

Device: drug eluting balloon catheter (trade name: Orchid)

Interventions

drug eluting balloon catheter (trade name: Orchid)DEVICE

use drug eluting balloon catheter(trade name: Orchid) to inflate the stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery

DCB arm

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with a more than 70% stenosis at femoral and/or popliteal artery meet all the inclusion and excluison criteria

You may qualify if:

  • Age between 18 and 80 years
  • Patients with peripheral artery disease (PAD), with Rutherford classification between 2 and 5
  • an occlusion or a minimum grade of stenosisPrimary over 70% in the superficial femoral artery an /or the popliteal artery
  • Total length of treat lesion(s)is less or equal to 20cm
  • signed Patient informed consent form

You may not qualify if:

  • plasma Cr level greater than 150 umol/L in patients
  • patients with acute thrombosis requiring lysis or thrombectomy
  • or more than 2 stenosis lesions in traget vessel
  • patient with a lysis or an lower limb intervention as a therapy within the last 6 weeks
  • patient requiring intervention in both lower limbs at the same time
  • have \>30% residual stenosis or blood-limited dissection after predilation
  • distal outflow through less than one lower leg vessel
  • known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium, etc.
  • patients participating in another clinical trials with interfere with this trial in the past 3 months
  • pregnancy and lactating woman
  • untreatable bleeding diatheses
  • other diseases, such as cancer, liver disease, or cardiac insufficiency, which may lead to protocol violations or markedly shorten a patients's life expectancy(less than 1 years)
  • patients unable or unwilling to participate this trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Peking University First Hospital

Beijing, Beijing Municipality, China

Location

The second hospital of hebei medical university

Shijiazhuang, Hebei, China

Location

The second affiliated hospital of Harbin medical university

Harbin, Heilongjiang, China

Location

Wuhan central hospital

Wuhan, Hubei, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Location

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Location

Tianjin First Center Hospital

Tianjin, Tianjin Municipality, China

Location

The First Affiliated Hospital of Zhejiang University

Nanjing, Zhejiang, China

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • Wei Guo

    Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

  • Yinghua Zou

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2017

First Posted

August 30, 2017

Study Start

January 19, 2018

Primary Completion

April 30, 2020

Study Completion

June 1, 2020

Last Updated

August 19, 2020

Record last verified: 2020-04

Locations

CN(10)