NCT03466749

Brief Summary

The aim of this Real-world study in China is evaluating the Safety and Efficacy of Paclitaxel Eluting Balloon Catheter in Coronary de-novo lesions(target vessel diameter:2.5mm-4.0mm)Treatment. And the primary point of this study is the target lesion failure of 12 months after surgery.

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
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

February 5, 2018

Completed
17 days until next milestone

Study Start

First participant enrolled

February 22, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 15, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

April 12, 2019

Status Verified

April 1, 2019

Enrollment Period

2 years

First QC Date

February 5, 2018

Last Update Submit

April 11, 2019

Conditions

Coronary Disease

Keywords

Coronary DiseaseDrug eluting balloonDe-novo lesions

Outcome Measures

Primary Outcomes (1)

  • TVF of 12 months after surgery

    target vessel failure of 12 months after surgery

    12 months after surgery

Study Arms (1)

Intervention group

EXPERIMENTAL

Paclitaxel Eluting Balloon Catheter treatment

Device: Paclitaxel Eluting Balloon Catheter

Interventions

Paclitaxel Eluting Balloon CatheterDEVICE

Paclitaxel Eluting Balloon Catheter

Intervention group

Eligibility Criteria

Age18 Years - 78 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age, male or non-pregnant female;
  • patients with asymptomatic or symptomatic myocardial ischemia, stable or unstable angina pectoris, myocardial infarction with a course of more than two weeks, and patients with indications for percutaneous coronary intervention;
  • the target lesions were primary, in situ coronary artery stenosis, located on one or two different coronary artery vessels, the number of target lesions on each coronary artery was not more than one;
  • the length of the target lesion ≤ 26mm (visual), which can be covered by a single drug balloon (it is suggested that the balloon should cover at least 4mm healthy partition, 2 mm at each end; The reference diameter of target vessel was 2.5mm-4.0mm (visual);
  • the stenosis degree of the target lesion was ≥ 70%;
  • left ventricular ejection fraction ≥ 45%.
  • patients who can understand the purpose of the trial, voluntarily participate and sign informed consent, and are willing to follow up the study.

You may not qualify if:

  • Related to patients:
  • patients with myocardial infarction within two weeks;
  • pregnant or lactating women;
  • cardiogenic shock, acute infection, known bleeding or coagulation disorder, or active digestive tract; Patients with history of hemorrhage or ulcer, cerebral hemorrhage or subarachnoid hemorrhage, stroke within half a year;
  • patients with a life expectancy less than one year or with difficulties in clinical follow-up;
  • patients who had a history of PTCA or had other operations scheduled during the follow-up period of one year;
  • patients who are participating in any other clinical study and who have not reached the main end point of the study;
  • present or previous history of severe liver disease, and / or renal impairment: serum creatinine \> 2.0 mg / dl( 176.8 umol / L) or undergoing hemodialysis therapy. Therefore, it does not meet the requirements of angiography;
  • patients with left ventricular ejection fraction below 45%;
  • for other reasons, the researchers did not think it was appropriate for a patient to be selected.
  • Related to lesions:
  • left main lesion and the bifurcation with side branch \>2.5 mm;
  • the location of the lesion was less than 10 mm at the proximal end of the anterior descending branch, 5 mm in the circumflex branch and 5 mm in the proximal end of the right coronary artery.
  • severe calcification and twisted lesions which can not be successfully predilated, are not suitable for drug balloon delivery and expansion.
  • lesion length ≥ 26 mm;
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ling Tao

Xi'an, Shannxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Ling Tao, Ph.D.,M.D.

    Xijing Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ling Tao, Ph.D.,M.D.

CONTACT

86-29-84775183lingtao2006@gmail.com

Zhiyong Yin, Ph.D.,M.D.

CONTACT

86-29-84775183zhiyong_yin@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
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

February 5, 2018

First Posted

March 15, 2018

Study Start

February 22, 2018

Primary Completion

February 22, 2020

Study Completion

December 31, 2020

Last Updated

April 12, 2019

Record last verified: 2019-04

Locations

CN(1)