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

NCT03625830 | Unknown DMC

• 1 other identifier: AAG-G-H-1518
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Small Vessel Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Paclitaxel-eluting PTCA-Balloon Catheter(SeQuent® Please)

EXPERIMENTAL

Device: Paclitaxel-eluting PTCA-Balloon Catheter(SeQuent® Please)

Rapid exchange PTCA Balloon Catheter (SeQuent® Neo)

ACTIVE COMPARATOR

Device: rapid exchange PTCA -Balloon Catheter (SeQuent® Neo)

Interventions

Paclitaxel-eluting PTCA-Balloon Catheter(SeQuent® Please) DEVICE

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.

Paclitaxel-eluting PTCA-Balloon Catheter(SeQuent® Please)

rapid exchange PTCA -Balloon Catheter (SeQuent® Neo) DEVICE

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.

Rapid exchange PTCA Balloon Catheter (SeQuent® Neo)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Study Sites (1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

Related Publications (1)

• Xu K, Fu X, Yang W, Wu Y, Li C, Ding D, Wang Z, Chu M, Qian J, He B, Tu S, Shen L, Ge J. A novel angiographic index for predicting the efficacy of drug-coated balloons in small vessels. EuroIntervention. 2025 Oct 20;21(20):e1209-e1221. doi: 10.4244/EIJ-D-25-00075.

  PMID: 41117656 DERIVED

Central Study Contacts

Jun Bo Ge

CONTACT

+86 21 64041990; lcsyjg@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: August 10, 2018
• Study Start: December 18, 2017
• Primary Completion: August 30, 2019
• Study Completion: December 30, 2019
• Last Updated: January 16, 2019

Record last verified: 2018-08

Locations

CN (1)