INTEGRAL study

Not Applicable

Recruiting

• Conditions: Diffuse/tandem Coronary Lesions

• Registration Number: JPRN-jRCTs072200027
• Lead Sponsor: Matsuo Hitoshi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-24
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1.>20 years of age
2.Willing to participate and able to understand, read, and sign the informed consent document before the planned procedure
3.Eligible for coronary angiography and/or percutaneous coronary intervention
4.Patient with at least 2 separate (>10mm apart) or diffuse (>20mm) de novo angiographically 50-90% stenoses in one native major epicardial vessel or their major branches (The stenosis will be regarded as single when the gap is 10mm or shorter between the 2 narrowings)
5.Single coronary artery disease
6.Stable coronary artery disease (with or without a history of PCI)

Exclusion Criteria

1.Previous CABG with patent grafts to the interrogated vessel
2.Total coronary occlusions
3.Cardiogenic shock, or intra-aortic balloon pumping
4.Contraindications to PCI or drug-eluting stent (DES) implantation
5.Malignant disease with unfavorable prognosis that may influence survival within the next 3 years
6.EF < 30%
7.eGFR < 15mL/min/1.73m2
8.Pregnant or planning to be pregnant
9.Frequent arrhythmia
10.Acute coronary syndrome or a history of myocardial infarction
11.Severe valvular heart disease
12.Distal coronary disease < 2.5 mm by visual estimation
13.Baseline flow < TIMI 3 or intracoronary thrombus
14.Included in other intervention trials
15.Weight > 200kg
16.Severe allergy to contrast media
17.Contraindications to antithrombotic therapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified