Compare the Efficacy and Safety of RESTORE DEB and SeQuent® Please in Chinese Patient With Coronary In-stent Restenosis

Coronary Restenosis Clinical Trial

Official title:

A Multicenter, Randomized, Controlled Study to Compare the Efficacy and Safety of 2 Types of Drug Eluting Balloon Catheters (RESTORE DEB and SeQuent® Please) in Chinese Patient With Coronary In-stent Restenosis (ISR)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02944890
• Other study ID #: RG01W-1101
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: May 2019

Study information

• Verified date: July 2017
• Source: ZhuHai Cardionovum Medical Device Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of Paclitaxel drug eluting balloons (RESTORE DEB, 3μg/mm2 balloon surface area ) for success of intervention treatment and maintaining the vessels unobstructed in the treatment of coronary in-stent restenosis compared with a product of the same category (SeQuent® Please).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: May 2019
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Related to the patients:

1. Age =18 years old

2. Patients agree to receive follow-ups in month-1, 6, 9 and 12, and receive angiography in month-9.

3. Patients are able to understand the objectives of the study mentally and in language. Patients should indicate sufficient compliance to the study, and acknowledge all risks and benefits by signing the informed consent form.

4. Patients with stable angina pectoris, or unstable angina pectoris, or old myocardial infarction, or proved asymptomatic regional myocardial ischemia

5. Patients suitable to receive coronary revascularization of any type (including balloon angioplasty, stent implantation or coronary artery bypass grafting)

Related to the diseases:

6. Restenosis Mehran type I-III after stent implantation (including bare metal stents, stents with inert coating, and stents with active coating) for the first time

7. Diameter of the stent with restenosis should be 2.5-4.0mm (included). Length of the stenosis lesion should be no more than 26mm, and diameter stenosis before operation should be =70%, or =50% with the evidence of ischemia.

8. One subject is allowed to have 2 target lesions at most, and 2 Paclitaxel drug balloons for dilation.

9. The distance between lesions which require intervention and the target lesions must be >10mm.

Exclusion Criteria:

Related to the patients:

1. Pregnant or lactating women, or women who plan to get pregnant within 12 months or refuse to take effective contraceptives.

2. The patients are participating in any other clinical trials before reaching the primary endpoints.

3. The patients have a life expectancy of less than 12 months, or it would be difficult to finish follow-ups within 12 months.

4. The patients had cerebral stroke within 6 months before being included, or have a history of peptic ulcer or gastrointestinal bleeding in the past 6 months, or the patients have a bleeding tendency according to the investigator.

5. Patients with a history of leukopenia (white blood cell count <3×109/L for more than 3 days) or neutropenia (ANC<1000/mm3 for more than 3 days) or thrombocytopenia (platelet <100,000/mm3)

6. Patients who are forbidden to use anticoagulation agents or anti-platelet drugs, and unable to tolerate Aspirin or Clopidogrel

7. Patients with renal insufficiency (eGFR<30mL/min)

8. Patients who are known to be allergic to Paclitaxel

9. Patients who had myocardial infarction within 1 week before being included

10. Patients who had heart transplantation

11. Patients with severe congestive heart failure or NYHA grade IV heart failure

12. Patients with severe valvular heart disease

13. Patients who are unsuitable for the study according to the investigator due to other reasons

Related to the diseases:

14. Patients with evidence of extensive thrombosis in the target vessel before intervention

15. Patients with total occlusion indicating TIMI 0 blood flow at the target lesion (Mehran type IV stenosis)

16. Patients with multiple lesions (=3) requiring percutaneous coronary intervention treatment in the same artery

17. Patients with lesions requiring intervention treatment in 3 vessels

18. The diameter of the branch lesions in the target lesion =2.5mm

19. Patients already treated with CABG after in-stent restenosis

20. LM lesions and Ostial lesion within 5mm to the root aorta

Related Conditions & MeSH terms

• Coronary Restenosis

Intervention

Device:
• Drug Eluting Balloon Catheters(RESTORE DEB)

• Drug Eluting Balloon Catheters(SeQuent® Please)

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital,Capital Medical University	Beijing	Beijing
China	Beijing Chaoyang Hospital	Beijing	Beijing
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing
China	Chinese PLA General Hospital	Beijing	Beijing
China	Cangzhou Central Hospital	Cangzhou	Hebei
China	The First Hospital of Jilin University	Changchun	Jilin
China	The Second Hospital of Jilin University	Changchun	Jilin
China	Daqing Oilfield General Hospital	Daqing	Heilongjiang
China	Sir Run Run Shaw Hospital School of medicine, Zhejiang University	Hangzhou	Zhejiang
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The First Hospital of Lanzhou University	Lanzhou	Gansu
China	Nanjing First Hospital	Nanjing	Jiangsu
China	Tianjin Chest Hospital	Tianjin	Tianjin
China	Tangdu Hospital	Xi'an	Shaanxi

Sponsors (2)

Lead Sponsor	Collaborator
ZhuHai Cardionovum Medical Device Co., Ltd.	R&G Pharma Studies Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-segment late lumen loss of the target lesion		9 months
Secondary	The success rate of intervention treatment: including device success, lesion success and clinical success		1-2 days
Secondary	Occurrence rate of restenosis in the target lesions		9 months after the operation
Secondary	Target lesion revascularization (TLR) rate		1, 6, 9, and 12 months after the operation
Secondary	Target vessel revascularization (TVR) rate		1, 6, 9, and 12 months after the operation
Secondary	Target lesion failure (TLF) rate		1, 6, 9, and 12 months after the operation
Secondary	Occurrence rate of major adverse cardiovascular events		1, 6, 9, and 12 months after the operation
Secondary	All adverse events and severe adverse events		1, 6, 9, and 12 months after the operation