Coronary DiseaseRESPECTNCT03466749
Paclitaxel Eluting Balloon Catheter in Coronary De-novo Lesions Treatment in China
A study testing Paclitaxel Eluting Balloon Catheter in people with Coronary Disease, run by Xijing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Coronary Disease
- What is being tested?
- Paclitaxel Eluting Balloon Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 22 Feb 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-78 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.
Who cannot join
- 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;
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- 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;
- evidence of severe thrombosis in target vessels before intervention;
- lesions that cannot be treated with PTCA or other interventional techniques;
- after predilation of the target lesion, residual stenosis ≥ 30% or TIMI blood flow < 3, and / or obvious flow limiting dissection.
- patients with bleeding constitution, anticoagulant or antiplatelet drugs;
- patients who cannot tolerate aspirin and / or clopidogrel or who have a history of neutropenia or thrombocytopenia or who have too severe liver failure to receive clopidogrel;
- patients known to be intolerant or allergic to heparin, contrast agents, paclitaxel, iopramide, rapamycin, polylactic acid-glycolic acid polymer, stainless steel, etc.
- leukopenia (leukocyte count < 3 × 109 / L and the course > 3 days) or neutropenia ANC < 1000 neutrophil / mm3 and the course> 3 days). Or patients had a history of thrombocytopenia (< 100,000 platelets / mm3;
- patients with a history of peptic ulcer or gastrointestinal bleeding in the past 6 months.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ling Tao
Xi'an, Shannxi, 710032
Ling Tao, +862984775183
About this study
Official title: A Real-world Study in China: the Safety and Efficacy of Paclitaxel Eluting Balloon Catheter in Coronary De-novo Lesions Treatment
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.
- Conditions
- Coronary Disease
- Being tested
- Paclitaxel Eluting Balloon Catheter
- Keywords
- Coronary Disease, Drug eluting balloon, De-novo lesions
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel Eluting Balloon CatheterDevice
Paclitaxel Eluting Balloon Catheter
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Paclitaxel Eluting Balloon Catheter treatment Receives: Device: Paclitaxel Eluting Balloon Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
TVF of 12 months after surgery
target vessel failure of 12 months after surgery
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start22 Feb 2018
- Primary completion22 Feb 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University, First Affiliated Hospital of Zhejiang University, Second Affiliated Hospital, Zhejiang University, School of Medicine, Second Hospital of Jilin University, First Affiliated Hospital of Xinjiang Medical University, Tang-Du Hospital, China-Japan Union Hospital, Jilin University, Xuzhou Third People's Hospital
- Responsible party
- Principal investigator, Ling Tao, Xijing Hospital
- Investigators
- Ling Tao, Ph.D.,M.D., Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03466749
- Sponsor's protocol ID
- KY20172081
- Acronym
- RESPECT
- Status last verified
- Apr 2019
- First submitted
- 5 Feb 2018
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study in China: the Safety and Efficacy of Paclitaxel Eluting Balloon Catheter in Coronary De-novo Lesions Treatment
- ClinicalTrials.gov ID
- NCT03466749
- Acronym / sponsor ID
- RESPECT / KY20172081
- Conditions
- Coronary Disease
- Keywords
- Coronary Disease, Drug eluting balloon, De-novo lesions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University, First Affiliated Hospital of Zhejiang University, Second Affiliated Hospital, Zhejiang University, School of Medicine, Second Hospital of Jilin University, First Affiliated Hospital of Xinjiang Medical University, Tang-Du Hospital, China-Japan Union Hospital, Jilin University, Xuzhou Third People's Hospital
- Study start
- 22 Feb 2018 (actual)
- Primary completion
- 22 Feb 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 15 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Paclitaxel Eluting Balloon CatheterPaclitaxel Eluting Balloon Catheter treatment |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18-78 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%;
Key exclusion criteria (23 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paclitaxel Eluting Balloon CatheterPaclitaxel Eluting Balloon Catheter | Device | Intervention group |
Primary outcome
TVF of 12 months after surgery
Time frame: 12 months after surgery
target vessel failure of 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ling Tao, Ph.D.,M.D. principal investigator
Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paclitaxel Eluting Balloon Catheter in people with Coronary Disease, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ling Tao, Ph.D.,M.D. (86-29-84775183, lingtao2006@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TVF of 12 months after surgery (time frame: 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2019.