Trial for MicroPort's DCB

NCT04386213 | Unknown DMC

• 1 other identifier: PROMISE-DCB
• Study Type: interventional
• Target: 216
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a multicenter, randomized, controlled clinical research and aims to evaluate the safety and efficacy of the paclitaxel drug-coated coronary artery balloon catheter in patients with coronary artery in-stent restenosis compared to seQuent® please paclitaxel drug-coated coronary artery balloon catheter.

Conditions

Coronary Artery In-stent Restenosis

Outcome Measures

Primary Outcomes (1)

• In-segment Late Lumen Loss

  In-segment Late Lumen Loss

  9 months after coronary angiography

Secondary Outcomes (12)

• Device success

  during the procedure

• Procedural success

  Immediately after the index procedure

• Clinical success

  At time of procedure up to 7 days in hospital

• Device-oriented composite endpoints (Target Lesion Failure)

  1 month, 6 months, 9 months, 1 year and 2 years after index procedure

• Patient-oriented composite endpoint (PoCE)

  1 month, 6 months, 9 months, 1 year and 2 years after index procedure

Study Arms (2)

Paclitaxel Drug-coated Balloon

EXPERIMENTAL

Device: coronary artery in-stent restenosis

SeQuent® Please Paclitaxel Drug-coated Balloon

ACTIVE COMPARATOR

Device: coronary artery in-stent restenosis

Interventions

coronary artery in-stent restenosis DEVICE

treat the petients with coronary artery in-stent restenosis

Paclitaxel Drug-coated Balloon; SeQuent® Please Paclitaxel Drug-coated Balloon

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age, males or non-pregnant females; 2.With silent ischemia evidence, patients with stable or unstable angina, or in patients with old myocardial infarction; 3.Restenosis after the first stent implantation, and more than 90 days after the stent implantation; 4.Patients with indications for coronary artery bypass graft surgery; 5.To understand the purpose of testing, voluntary and informed consent, patients undergoing invasive imaging follow-up.
• One or two target lesions;
• Restenosis in the stent (including bare stent, permanent coating and biodegradable coating) : Mehran I, II and III stenosis;The diameter of the reference vessel ranges from 2.0mm to 4.0mm, and the length ≤40mm;
• The original stent diameter stenosis before surgery must be ≥70% or ≥50% with local ischemia;
• There should be no more than two lesions requiring interventional treatment, and the distance between the two lesions must be \>10mm.

You may not qualify if:

• Within 1 week of any acute myocardial infarction or myocardial enzymes did not return to normal;
• Severe congestive heart failure (NYHA III and above) ,or left ventricular ejection fraction \<30% (ultrasound or left ventricular angiography);
• The unstable arrhythmia, such as high risk ventricular extrasystole and ventricular tachycardia;
• Blood test prompted platelet counts of less than 100x10E9/L or greater than 700x10E9/L, white blood cells than 3x10E9/L; which was judged to be clinically significant by the researchers;
• Preoperative renal function serum creatinine \>2.0mg/DL; receiving hemodialysis;
• Subjects with bleeding tendency, antiplatelet preparation and anticoagulant treatment contraindications, subjects unable to receive antithrombotic treatment, or subjects unable to tolerate DAPT treatment for three months;
• Previous history of peptic ulcer or gastrointestinal bleeding within 6 months;
• Patients with cerebral vascular accident or transient ischemic attack (TIA) within the previous 6 months, or with permanent neurological defects that may lead to non-compliance with the protocol;
• Allergic to aspirin, heparin, contrast agent, polylactic acid polymer and paclitaxel;
• The life expectancy of the subjects is less than 12 months;
• The researcher judged that the subjects had poor compliance and could not complete the study as required;Or for other reasons that the researchers consider inappropriate;
• Subjects who are participating in any other clinical trial, or who have participated in clinical trials of other drugs or medical devices before being enrolled and have not reached the main study endpoint;
• Pregnant or breast-feeding female subjects (women who may be pregnant must undergo a pregnancy test 7 days prior to baseline surgery).
• In-stent restenosis without successful predilatation;
• Stent restenosis of vein grafts;

Sponsors & Collaborators

• Shanghai MicroPort Medical (Group) Co., Ltd.: lead

Central Study Contacts

Ling Tao

CONTACT

13636498543; clfeng@microport.com

Ling Tao

CONTACT

029-84775507; webmaster@fmmu.edu.cn

Study Design

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

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 13, 2020
• Study Start: September 1, 2020
• Primary Completion: December 1, 2023
• Study Completion: July 31, 2025
• Last Updated: May 13, 2020

Record last verified: 2020-05