Drug-coated Balloon Therapy for In-stent Restenosis and de Novo Coronary Lesions

October 24, 2022 updated by: Chunjian Li, The First Affiliated Hospital with Nanjing Medical University

Clinical Prognosis and Influencing Factors of Drug-coated Balloon Therapy in Patients With Coronary In-stent Restenosis and de Novo Coronary Lesions

This was a single-center, prospective, open-label, observational study. Patients with coronary artery disease confirmed by coronary angiography and treated with drug-coated balloon catheter alone for target vessels were enrolled in the Cardiology Department of our hospital in January 2022. The primary endpoint was late lumen loss within 12±3 months after surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • The First Affiliated Hospital of Nanjing Medical University
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with coronary heart disease by coronary angiography and treated with DCB alone in the Department of Cardiology of our hospital since January 2022 were included in this study.

Description

Inclusion Criteria:

  1. Patients aged ≥18 years with coronary heart disease;
  2. If the target lesion stenosis ≥70% is complicated with angina pectoris or evidence of myocardial ischemia, DCB should be administered;
  3. Residual lumen diameter stenosis ≤30% after lesion pretreatment and DCB, no vessel dissection, or type A or B dissection, and TIMI blood flow level 3;
  4. Target lesions were treated with DCB for the first time.

Exclusion Criteria:

  1. Intraoperative implantation of salvage stent in DCB;
  2. Acute myocardial infarction occurred within 1 week after DCB operation;
  3. Less than 3 months of dual antiplatelet therapy after DCB operation, or more than 1 month of discontinuation of antiplatelet therapy;
  4. The position of the stent could not be determined by coronary angiography.
  5. Desmovascular disease or left main artery disease;
  6. Atrial fibrillation;
  7. Patients with severe heart failure, valvular heart disease, renal insufficiency, severe infection and autoimmune disease.

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: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
De novo coronary lesions: cutting balloon group
De novo coronary lesions were pretreated with a cutting balloon and then treated with a drug-coated balloon.
Procedure: Pretreatment strategies before drug balloon therapy
Preconditioning strategies for the treatment of in de novo coronary lesions using drug-coated balloons.
De novo coronary lesions: non-cutting balloon group
De novo coronary lesions were pretreated with a non-cutting (Compliance balloon or/and non-compliant balloon) balloon and then treated with a drug-coated balloon.
Procedure: Pretreatment strategies before drug balloon therapy
Preconditioning strategies for the treatment of in de novo coronary lesions using drug-coated balloons.
In-stent restenosis: Type-I
Body stenosis: restenosis of the stent body, not beyond the edge of the stent.The lesions were pretreated with balloon dilation and then treated with drug-coated balloons.
Procedure: Different types of in-stent restenosis were treated with drug-coated balloons
A new classification method of ISR lesions was proposed to observe the clinical prognosis of different ISR lesions treated with drug-coated balloon.
In-stent restenosis: Type-II
Marginal stenosis type: restenosis at the edge of the stent, stenosis ≥50% within 5mm of the stent edge, which can continue into the stent.The lesions were pretreated with balloon dilation and then treated with drug-coated balloons.
Procedure: Different types of in-stent restenosis were treated with drug-coated balloons
A new classification method of ISR lesions was proposed to observe the clinical prognosis of different ISR lesions treated with drug-coated balloon.
In-stent restenosis:Type-III
Diffuse proliferative type: the lesion extends to the whole scaffold body and beyond the edge of both ends.The lesions were pretreated with balloon dilation and then treated with drug-coated balloons.
Procedure: Different types of in-stent restenosis were treated with drug-coated balloons
A new classification method of ISR lesions was proposed to observe the clinical prognosis of different ISR lesions treated with drug-coated balloon.
In-stent restenosis:Type-IV
Complete occlusion type: complete occlusion in the stent.The lesions were pretreated with balloon dilation and then treated with drug-coated balloons.
Procedure: Different types of in-stent restenosis were treated with drug-coated balloons
A new classification method of ISR lesions was proposed to observe the clinical prognosis of different ISR lesions treated with drug-coated balloon.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
LLL of 12±3 months after surgery
Time Frame: 12±3 months after surgery
Late lumen loss of 12±3 months after surgery
12±3 months after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
MACE event 12 months after surgery
Time Frame: 12 months after surgery
The incidence of MACE events (target vessel revascularization, target vessel myocardial infarction, cardiac death) at 12 months after surgery.
12 months after surgery

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First Affiliated Hospital with Nanjing Medical University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 26, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings