The Efficacy and Safety of SeQuent® Please in the Treatment of Small Vessel Disease (SVD) Patient

A Randomized, Multicenter Study on the Efficacy and Safety of Paclitaxel-eluting PTCA-Balloon Catheter(SeQuent® Please) Compared to POBA in the Treatment of Small Vessel Disease (SVD) Patient

The purpose is to evaluate the safety and effectiveness of paclitaxel-releasing coronary balloon (Catheter SeQuent® Please) versus rapid exchange PTCA balloon catheter (SeQuent® Neo) in the treatment of stenoses of coronary small vessels. 270 subjects will be enrolled for the trials.

Study Overview

• Status: Unknown
• Conditions: Small Vessel Disease
• Intervention / Treatment: Device: Paclitaxel-eluting PTCA-Balloon Catheter(SeQuent® Please); Device: rapid exchange PTCA -Balloon Catheter (SeQuent® Neo)

• Study Type: Interventional
• Enrollment (Anticipated): 270
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jun Bo Ge; Phone Number: 2745 +86 21 64041990; Email: lcsyjg@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Zhongshan Hospital Fudan University
      • Contact: Jun Bo Ge, Academician; Phone Number: 2745 +86 21 64041990; Email: ge.junbo@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Criteria related to subjects

• Patients with stable angina pectoris, or unstable angina pectoris, or old myocardial infarction, or documented silent ischemia;
• At the age of 18-80;
• Women of childbearing potential may not be pregnant nor have the desire to becoming pregnant during the study. Hence, patients will be advised to use an adequate birth control method up to (including) the end of follow-up;
• Patients must agree to undergo the 9-month angiographic follow-up and the clinical follow-up at 30 days, 6 months, 9 months and 12 months after operation;
• Patients who are psychologically and linguistically able to understand the purpose of the study, and show sufficient compliance with the study protocol;
• Patients who have expressed acknowledgment of the risks and benefits described in the informed consent document by providing informed consent;

Criteria related to lesions

• The target lesion is primary, in situ coronary artery lesion located in 1 or 2 different coronary arteries, with no more than 1 target lesion in each coronary artery;
• The reference vessel diameter is within the range of 2.0 mm - 2.75 mm; (visually measured)
• Interventional treatment should be conducted on lesion(s) of non-target vessel(s) in advance (which must be concurrent treatment), and management of random and target lesions should be performed after successful treatment of non-target lesion(s);
• The pre-operative diameter stenosis must be either ≥ 70% or ≥ 50% with ischemia; (visually measured)
• Each target lesion should be treated with only one SeQuent® Please or SeQuent® Neo.

Exclusion Criteria:

Criteria related to subjects

• Patients with recent myocardial infarction (within one week), or patients with myocardial infarction over one week but whose troponin level has not recovered to normal;
• Patients with severe congestive heart failure or NYHA class IV heart failure;
• Patients with severe valvular heart disease;
• Women who are pregnant or lactating;
• Patients with remaining life expectancy of no more than 1 year or with factors causing difficulty in clinical follow-up;
• Patients who had cerebral stroke within 6 months before operation;
• Patients who are currently involved in any other clinical trial;
• Patients with presence or history of severe hepatic failure and therefore are not eligible for angiography;
• Patients with presence or history of severe renal failure (GFR < 30 ml/min) and therefore are not eligible for angiography;
• Patients who have received heart transplant;
• Patients with cardiogenic shock;
• Patients with left ventricular ejection fraction less than 30%;
• Patients suffering from coronary artery spasm without significant stenosis;
• Patients considered as ineligible by the investigator for other reasons;

Criteria related to lesions

• Evidence of extensive thrombosis in target vessel before intervention;
• Percutaneous coronary intervention of venous graft;
• Chronic total occlusion (TIMI 0 flow before operation);
• Left main disease and/or triple vessel disease needed to be treated, bifurcation lesion with branch vessel diameter ≥ 2.5 mm, and bypass graft lesion;
• There is non-target lesion(s) in the proximal large vessel and target lesion(s) in the distal small vessel of the same vessel (eligible if there is non-target lesion(s) in proximal large vessel and a target lesion in the bifurcated small vessel);
• The target vessel is distorted or has calcified lesion(s);
• Lesion within 5 mm away from the coronary artery ostium;
• Lesion that cannot be treated with PTCA or other interventional techniques;
• After pre-dilation of target lesion, the residual stenosis is ≥ 30% or TIMI flow is < 3, and/or type C or above dissection appears;

Exclusion criteria related to concomitant medication

• Patients prone to bleeding and contraindicated for anticoagulant or antiplatelet drugs;
• 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;
• Patients with a history of leukopenia (leukocyte count < 3 × 109/L for more than 3 days), neutrophilopenia (ANC < 1,000 neutrophils/mm3 for more than 3 days), or thrombocytopenia (< 100,000 platelets/mm3);
• 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: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Paclitaxel-eluting PTCA-Balloon Catheter(SeQuent® Please)	Device: Paclitaxel-eluting PTCA-Balloon Catheter(SeQuent® Please); SeQuent® Please in length of 10 mm, 15 mm, 17 mm, 20 mm, 26 mm, 30 mm and in diameter of 2.0 mm, 2.5mm, 2.75mm will be used in the trial.
Active Comparator: Rapid exchange PTCA Balloon Catheter (SeQuent® Neo)	Device: rapid exchange PTCA -Balloon Catheter (SeQuent® Neo); SeQuent® Please in length of 10 mm, 15 mm, 17 mm, 20 mm, 26 mm, 30 mm and in diameter of 2.0 mm, 2.5mm, 2.75mm will be used in the trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Late lumen loss in segment section at M9	To measure the diameter loss in the in-segment late lumen loss (LLL) at 9 months after operation by using angiography	9 months

Collaborators and Investigators

• Sponsor: B. Braun Medical International Trading Company Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2017
• Primary Completion (Anticipated): August 30, 2019
• Study Completion (Anticipated): December 30, 2019

Study Registration Dates

• First Submitted: August 7, 2018
• First Submitted That Met QC Criteria: August 7, 2018
• First Posted (Actual): August 10, 2018

Study Record Updates

• Last Update Posted (Actual): January 16, 2019
• Last Update Submitted That Met QC Criteria: January 15, 2019
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: AAG-G-H-1518

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No