PCB for Long De Novo Lesions of Main Coronary Arteries (D-Lesion Long Trial)

Efficacy and Safety of Paclitaxel-Coated Balloon Catheter in Patients With Long De Novo Lesions of Main Coronary Arteries

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

Study Overview

• Status: Unknown
• Conditions: Stable Angina Pectoris; Unstable Angina Pectoris
• Intervention / Treatment: Device: Paclitaxel-Coated Balloon

Detailed Description

Paclitaxel-Coated Balloon Catheter is a new device in coronary disease, it can inhibit the proliferation of smooth muscle of coronary vessels by transitory contaction, without residual implantation.

More and more evidences have shown its efficacy and safety in diffuse small coronary disease, bifurcation disease and in-stent restenosis. But there are still seldom evidences in De Novo Lesions of Main Coronary Arteries.

PCB has used in some subgroup of many study but confused with in-stent renstenosis or small coronary disease. The investigators designed this study to evaluate the Efficacy and Safety of Paclitaxel-Coated Balloon Catheter in Patients With Diffuse Long De Novo Lesions of Main Coronary Arteries.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fei Xia; Phone Number: +8617702487875; Email: xf19870421@126.com
• Study Contact Backup: Name: Zhilin Miao; Phone Number: +8617702487775; Email: miaozl2049@sina.com

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110016
      • The People's Hospital of Liaoning Province
      • Contact: Aijie Hou
      • Contact: Xizhuang Bai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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)；
2. a lesion diameter stenosis >75% as evaluated by QCA with a reference diameter of ≥ 2.75 mm and ≤ 3.5 mm .
3. 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.
4. a willingness to receive DCB angioplast or DES implantation.

Exclusion Criteria:

1. Patients with acute myocardial infarction within 30 days；
2. a previous history of severe valvular heart disease,severe hepatic and renal insufficiency；severe cardiac dysfunction with EF≤40%；
3. advanced cancer with a life expectancy of <12 months；
4. Patients with abnormal coagulation function, Contraindications for antiplatelet drugs or unable to tolerate antiplatelet therapy;
5. Pregnant and lactating patients；
6. Multiple vessels involvement or multiple lesions requiring intervention treatment,left main artery lesions and coronary artery bypass graft lesions；
7. Stent restenosis
8. 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°）
9. 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）.

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: PCB group; 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; SeQuent ® Please; B.Braun, Melsungen, Germany; Other Names: Drug-coated balloon (DCB)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The People's Hospital of Liaoning Province
• Investigators: Principal Investigator: Aijie Hou, The People's Hospital of Liaoning Province

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2017
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): February 1, 2019

Study Registration Dates

• First Submitted: May 15, 2017
• First Submitted That Met QC Criteria: May 15, 2017
• First Posted (Actual): May 16, 2017

Study Record Updates

• Last Update Posted (Actual): May 16, 2017
• Last Update Submitted That Met QC Criteria: May 15, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Drug-Coated Balloon; Main Coronary Artery; De Novo Lesion
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Angina, Stable; Angina, Unstable; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: CTC-91919

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