Optical Coherence Tomography Guided Percutaneous Coronary Intervention for Drug-eluting In-stent Restenosis

Percutaneous Coronary Intervention Clinical Trial

Official title:

Optical Coherence Tomography Guided Percutaneous Coronary Intervention for Drug-eluting In-stent Restenosis: A Prospective Registry Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03809754
• Other study ID #: Z171100001017158
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: September 1, 2020

Study information

• Verified date: January 2019
• Source: Chinese PLA General Hospital
• Contact: Yundai Chen
• Phone: +8601055499135
• Email: yundaichen[@]vip.163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a prospective, registry trial aimed to compare the clinical and angiographic outcomes of OCT-guided and angiography-guided PCI in patients with coronary DES-ISR.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: September 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years or older

• Patients with angina or evidence of myocardial ischaemia

• Patients with restenotic lesions in a previously DES area of a coronary artery

• Patients suitable to receive any types of percutaneous coronary intervention (including balloon angioplasty and stent implantation)

• The stent diameter of DES-ISR is 2.5mm to 4.0mm

• Target lesion length < 30mm

• Target lesion stenosis = 70% diameter stenosis on visual assessment, or = 50% diameter stenosis and with evidence of myocardial ischaemia ischemic

Exclusion Criteria:

• Patients with acute myocardial infarction with 1 week

• Patients with evidence of extensive thrombosis in the target vessel

• Patients with left main coronary artery disease

• Patients with cardiogenic shock, left ventricular ejection fraction < 40%,significant renal dysfunction and severe heart valve disease

• Patients who had cerebral stroke within 6 months before PCI

• Patients with a life expectancy < 1 year

• Patients not able to adhere to follow-up visits

Related Conditions & MeSH terms

• CHD - Coronary Heart Disease
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• In-stent Restenosis
• Myocardial Ischemia
• Percutaneous Coronary Intervention

Intervention

Procedure:
• Percutaneous Coronary Intervention under OCT
After randomization, subjects receive primary PCI under the guiding of OCT
• Percutaneous Coronary Intervention under Angiography
After randomization, subjects receive primary PCI under the guiding of angiography

Locations

Country	Name	City	State
China	Yundai Chen	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-segment late loss at 9 months follow-up		9 months
Secondary	Rates of acute success		1 month
Secondary	Rate of 9-month binary restenosis		9 months
Secondary	Number of Participants with target lesion failure (TLF)		12 months
Secondary	Rate of major adverse cardiovascular events		12 months
Secondary	Number of participants with all-cause death		12 months
Secondary	Rate of myocardial infarction		12 months