NCT03155971

Brief Summary

This study evaluates the Efficacy and Safety of Paclitaxel-Coated Balloon Catheter in Patients With Diffuse Long De Novo Lesions of Main Coronary Arteries.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2017

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

May 15, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 16, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

May 16, 2017

Status Verified

May 1, 2017

Enrollment Period

1.5 years

First QC Date

May 15, 2017

Last Update Submit

May 15, 2017

Conditions

Stable Angina PectorisUnstable Angina Pectoris

Keywords

Drug-Coated BalloonMain Coronary ArteryDe Novo Lesion

Outcome Measures

Primary Outcomes (1)

  • QCA late lumen loss

    minimal lumen diameter at post-procedure minus minimal lumen diameter at 9 months follow-up measured by QCA(quantitative coronary angiography)

    Immediately after the procedure and at 9 months follow-up

Study Arms (1)

PCB group

EXPERIMENTAL

Prospective, single center, single-group clinical study. Interventions: Patients in the PCB group will be treated (angioplasted) with Paclitaxel-Coated Balloon (SeQuent ® Please; B.Braun, Melsungen, Germany)

Device: Paclitaxel-Coated Balloon

Interventions

Paclitaxel-Coated BalloonDEVICE

SeQuent ® Please; B.Braun, Melsungen, Germany

Also known as: Drug-coated balloon (DCB)
PCB group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a diagnosis of stable angina or unstable angina in hospitalized patients. Objective clinical evidence of ischemia (ECT, Exercise ECG, ECG ST-T changes) With CAG proven one vessel lesion（a lesion length of ≥ 20mm)；
  • a lesion diameter stenosis \>75% as evaluated by QCA with a reference diameter of ≥ 2.75 mm and ≤ 3.5 mm .
  • a willingness or ability to provide informed consent，a willingness to receive telephone followed-up at postoperative 1 month, 3 month, 6 month, and an angiographic follow up at postoperative 9 month.
  • a willingness to receive DCB angioplast or DES implantation.

You may not qualify if:

  • Patients with acute myocardial infarction within 30 days；
  • a previous history of severe valvular heart disease,severe hepatic and renal insufficiency；severe cardiac dysfunction with EF≤40%；
  • advanced cancer with a life expectancy of \<12 months；
  • Patients with abnormal coagulation function, Contraindications for antiplatelet drugs or unable to tolerate antiplatelet therapy;
  • Pregnant and lactating patients；
  • Multiple vessels involvement or multiple lesions requiring intervention treatment,left main artery lesions and coronary artery bypass graft lesions；
  • Stent restenosis
  • Thrombotic disease，severe calcified lesions（Judged by the operator， CAG showed class 2 or more severe calcified lesions），spontaneous dissection or ulcerative lesion，coronary ostial lesions (the lesion included should be an interval of greater than 3mm from the ostial of RCA or LAD)， severe angulated lesions（\>45°）
  • diameter of collateral vessel≥ 2.25 mm requiring interventional therapy,type 1 coronary lesions（Patients with diameter of collateral vessel\< 2.25 mm， who were not treated with DCB dilatation were also eligible）.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The People's Hospital of Liaoning Province

Shenyang, Liaoning, 110016, China

Location

MeSH Terms

Conditions

Angina, StableAngina, Unstable

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Aijie Hou

    The People's Hospital of Liaoning Province

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fei Xia

CONTACT

+8617702487875xf19870421@126.com

Zhilin Miao

CONTACT

+8617702487775miaozl2049@sina.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
Vice-Director of Department of Cardiology

Study Record Dates

First Submitted

May 15, 2017

First Posted

May 16, 2017

Study Start

July 1, 2017

Primary Completion

January 1, 2019

Study Completion

February 1, 2019

Last Updated

May 16, 2017

Record last verified: 2017-05

Locations

CN(1)