The Safety and Efficacy of SeQuent® Please in Real World Chinese Coronary Instent Restenosis Patients

August 8, 2018 updated by: B. Braun Medical International Trading Company Ltd.

To Evaluate the Long Term Safety and Efficacy of Drug Coated Balloon SeQuent® Please in Chinese Coronary Instent Restenosis Patients,a Prospective, Multi-center,Randomization Clinical Trial.

The purpose of this study is to evaluate the efficacy and safety of paclitaxel -eluting PTCA- balloon (SeQuent® Please) in real world Chinese Coronary In Sentrestenosis patients

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

520

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patient with coronary In sentrestenosis

Description

Inclusion Criteria:

Criteria related to subjects

  • At the age of 18-80, Both male and female;
  • Patients with coronary In sentrestenosis and suitable for the theory of Drug Eluting PTCA Balloon Catheter（SeQuent® Please）, no more than 1 target lesion in each coronary artery
  • After pre-dilation of target lesion, the residual stenosis is ≥ 30% , patients with type B dissection
  • Patients must agree to sign the ICF and to undergo the clinical follow-up at 30 days, 6 months, 6 months, 12 months, 24 months, 36months, 48 months and 60 months after operation Criteria related to lesions
  • The target lesion length and target vessel diameter should be consistent with the instructions of Drug Eluting PTCA Balloon Catheter（SeQuent® Please）

Exclusion Criteria:

Criteria related to subjects

  • Women with pregnancy or lactation
  • Patient with cardiac shock
  • Patients with Hemorrhagic physique or active gastrointestinal ulcers, with cerebral apoplexy or transient cerebral ischemia within 3 months, who couldn't be tolerated the expected aspirin and/or clopidogrel theory
  • Patients with severe valvular heart disease
  • Patients with severe congestive heart failure or NYHA class IV heart failure;
  • Patients who have received heart transplant;
  • Patients with life expectancy more than 60 months, or those who is difficulties in clinical follow-up.
  • Patients who are currently involved in any other clinical trial;
  • Patients that the investigators think that those are not suitable Criteria related to lesions
  • Chronic total occlusion
  • Lesion that cannot be treated with PTCA or other interventional techniques;
  • The vessel diameter < 2.25 mm
  • Left main disease needed to be treated Exclusion criteria related to concomitant medication
  • Patients who are intolerant to aspirin and/or clopidogrel or have a history of neutrophilopenia or thrombocytopenia, or patients with severe hepatic insufficiency and contraindicated for clopidogrel.
  • Patients who are known to be intolerant or allergic to heparin, contrast agent, paclitaxel, iopromide, rapamycin, polylactic acid - glycolic acid polymer, stainless steel;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target Lesion Failure in 12 months after operation
Time Frame: 1 year
To measure Target Lesion Failure in 12 months by using angiography
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

B. Braun Medical International Trading Company Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2015

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

August 7, 2018

First Submitted That Met QC Criteria

August 8, 2018

First Posted (Actual)

August 10, 2018

Study Record Updates

Last Update Posted (Actual)

August 10, 2018

Last Update Submitted That Met QC Criteria

August 8, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAG-O-H-1414

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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