Paclitaxel Eluting Balloon Catheter in Coronary De-novo Lesions Treatment in China (RESPECT)

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Disease
• Intervention / Treatment: Device: Paclitaxel Eluting Balloon Catheter

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shannxi
    • Xi'an, Shannxi, China, 710032
      • Recruiting
      • Ling Tao
      • Contact: Ling Tao; Phone Number: +862984775183

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 18-78 years of age, male or non-pregnant female;
2. 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;
3. 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;
4. 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);
5. the stenosis degree of the target lesion was ≥ 70%;
6. left ventricular ejection fraction ≥ 45%.
7. patients who can understand the purpose of the trial, voluntarily participate and sign informed consent, and are willing to follow up the study.

Exclusion Criteria:

Related to patients:

1. patients with myocardial infarction within two weeks;
2. pregnant or lactating women;
3. 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;
4. patients with a life expectancy less than one year or with difficulties in clinical follow-up;
5. patients who had a history of PTCA or had other operations scheduled during the follow-up period of one year;
6. patients who are participating in any other clinical study and who have not reached the main end point of the study;
7. 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;
8. patients with left ventricular ejection fraction below 45%;
9. for other reasons, the researchers did not think it was appropriate for a patient to be selected.

Related to lesions:

1. left main lesion and the bifurcation with side branch >2.5 mm;
2. 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.
3. severe calcification and twisted lesions which can not be successfully predilated, are not suitable for drug balloon delivery and expansion.
4. lesion length ≥ 26 mm;
5. evidence of severe thrombosis in target vessels before intervention;
6. lesions that cannot be treated with PTCA or other interventional techniques;
7. after predilation of the target lesion, residual stenosis ≥ 30% or TIMI blood flow < 3, and / or obvious flow limiting dissection.

Exclusion criteria related to drugs:

1. patients with bleeding constitution, anticoagulant or antiplatelet drugs;
2. 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;
3. patients known to be intolerant or allergic to heparin, contrast agents, paclitaxel, iopramide, rapamycin, polylactic acid-glycolic acid polymer, stainless steel, etc.
4. 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;
5. patients with a history of peptic ulcer or gastrointestinal bleeding in the past 6 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Paclitaxel Eluting Balloon Catheter treatment	Device: Paclitaxel Eluting Balloon Catheter; Paclitaxel Eluting Balloon Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TVF of 12 months after surgery	target vessel failure of 12 months after surgery	12 months after surgery

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Collaborators: Second Affiliated Hospital, School of Medicine, Zhejiang University; First Affiliated Hospital of Zhejiang University; The First Affiliated Hospital of Zhengzhou University; Tang-Du Hospital; First Affiliated Hospital of Xinjiang Medical University; Second Hospital of Jilin University; China-Japan Union Hospital, Jilin University; Xuzhou Third People's Hospital
• Investigators: Principal Investigator: Ling Tao, Ph.D.,M.D., Xijing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2018
• Primary Completion (Anticipated): February 22, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: March 14, 2018
• First Posted (Actual): March 15, 2018

Study Record Updates

• Last Update Posted (Actual): April 12, 2019
• Last Update Submitted That Met QC Criteria: April 11, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Coronary Disease; Drug eluting balloon; De-novo lesions
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Coronary Disease; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: KY20172081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No