Evaluation of the Efficacy and Safety of a Paclitaxel Eluting PTCA Balloon Catheter in Coronary In-stent Restenosis
NCT ID: NCT04213378
Last Updated: 2019-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
212 participants
INTERVENTIONAL
2017-01-01
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Paclitaxel eluting PTCA balloon
Treatment of coronary in-stent restenosis with paclitaxel eluting PTCA balloon
Paclitaxel eluting PTCA balloon
Treatment of coronary in-stent re-stenosis with paclitaxel eluting PTCA balloon
SeQuent® Please paclitaxel eluting balloon
Treatment of coronary in-stent restenosis with SeQuent® Please paclitaxel eluting balloon
SeQuent® Please paclitaxel eluting balloon
Treatment of coronary in-stent re-stenosis with SeQuent® Please paclitaxel eluting balloon
Interventions
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Paclitaxel eluting PTCA balloon
Treatment of coronary in-stent re-stenosis with paclitaxel eluting PTCA balloon
SeQuent® Please paclitaxel eluting balloon
Treatment of coronary in-stent re-stenosis with SeQuent® Please paclitaxel eluting balloon
Eligibility Criteria
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Inclusion Criteria
1. Patients with age between 18 and 80 years old (including 18 and 80 years old);
2. Patients with stable angina, or unstable angina pectoris, or old myocardial infarction (MI) or with evidence of local myocardial ischemia although without symptoms;
3. Patients with restenosis after the first time stent implantation of de novo coronary lesions (i.e., no other surgical treatments for the target lesions except for the first stent implantation);
4. Patients with the willing to receive their own coronary angioplasty;
5. Patients with LVEF\>30% measured within 30 days before recruitment;
6. Patients agree to receive 9-month angiography follow-up, and agree to receive 30 days, 6 months, 12 months clinical follow-up;
7. Patients at the age of childbirth must take effective contraception measures until the study is completed since they are chosen into screening period;
8. Patients agree to take part in the trial and sign the informed consent.
* Lesions oriented (Visual estimation)
1. Patients with Mehran type I, type II and type III in-stent restenosis (ISR);
2. Reference vascular diameter between 2.0-4.0 mm (including 2.0 and 4.0 mm), length\<30mm;
3. The percent of lumen ISR ≥70%, or ≥50% with local ischemia evidence before interventional surgery;
4. Patients with residual stenosis ≤30%, and ≤ type B dissection post pretreatment;
5. Distance between other lesions that require treatment and target lesions \>10 mm;
6. Patients with coronary artery anatomy allowing delivery of research device to target lesions.
Exclusion Criteria
1. Subjects with consistent clinical symptoms and/or ECG changes and/or cardiac enzymes changes with MI (including STEMI and Non-STEMI) within one week;
2. Subjects with cardiac shock, hemodynamic instability or refractory ventricular arrhythmia that require positive inotropic drugs or mechanical circulation support;
3. Subjects with one of following conditions (from screening period to the day of operation): (1) life expectancy is less than 1 year because of other severe diseases (like cancer), (2) drug abuse at present (like alcohol, cocaine, heroin and so on), (3) plan to accept surgery that may cause the programs not to be complied with or confusing with data understanding;
4. Subjects with bleeding diathesis or active gastrointestinal ulcers, or stroke/transient ischemic attack within 3 months;
5. Subjects with severe congestive heart failure or severe heart failure at the level of NYHA IV;
6. Subjects are receiving dialysis or baseline serum creatinine levels\>2.0 mg/dL(177μmol/L);
7. Subjects with severe valvular heart disease;
8. Subjects who have been or are scheduled for a heart transplantation during the trial;
9. Subjects who have been pregnant or is planning to be pregnant or is breastfeeding during the trial;
10. Subjects who are participating in any other clinical trial;
11. Researchers don't think they're suitable for the trial because of other reasons;
* Lesions oriented (Visual estimation)
1. Total occlusion with TIMI 0 (Mehran IV stenosis);
2. With the evidence of widespread thrombi in the target vessels prior to intervention;
3. Planning to treat \>3 lesions (i.e., up to 3 target lesions);
4. Planning to treat \>2 major epicardial vessels (i.e., up to 2 target lesions);
5. Planning to treat a single lesions with more than 1 balloon;
6. Planning to treat a true bifurcation lesion with double stents technique;
7. Left main lesions.
* Combined medication oriented
1. Subjects known to intolerant to dual antiplatelet therapy for 3 months post interventional treatment (e.g., aspirin and/or ticagrelor and/or clopidogrel);
2. Subjects with leukopenia (WBC\<3x10\^9/L for more than 3 days) or neutropenia (NEUT\<1x10\^9/L for more than 3 days) or a history of platelet reduction (PLT 30x10\^9/L);
3. Subjects known to be intolerant or allergic to paclitaxel.
18 Years
80 Years
ALL
No
Sponsors
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West China Hospital
OTHER
First Affiliated Hospital of Wenzhou Medical University
OTHER
Second Affiliated Hospital of Wenzhou Medical University
OTHER
The Third Xiangya Hospital of Central South University
OTHER
Hebei Medical University Third Hospital
OTHER
TEDA International Cardiovascular Hospital
OTHER
Tianjin People's Hospital
OTHER
The Second Hospital of Shandong University
OTHER
Hainan People's Hospital
OTHER
The First Affiliated Hospital of Xiamen University
OTHER
Shanghai Chest Hospital
OTHER
Renmin Hospital of Wuhan University
OTHER
Taizhou Hospital
OTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Principal Investigators
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Jian-an Wang, MD, PhD
Role: STUDY_CHAIR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Locations
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Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Jun Jiang, MD, PhD
Role: primary
References
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Xue W, Ma J, Yu X, Ruan Z, Sun Y, Wu T, Zhang X, Wu L. Analysis of the incidence and influencing factors associated with binary restenosis of target lesions after drug-coated balloon angioplasty for patients with in-stent restenosis. BMC Cardiovasc Disord. 2022 Nov 20;22(1):493. doi: 10.1186/s12872-022-02923-z.
Other Identifiers
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SAHZJU CT016
Identifier Type: -
Identifier Source: org_study_id