Optimized Strategies for Complex and High-risk Coronary Intervention of Chronic Total Occlusion

Optimized Strategies for Complex and High-risk Coronary Intervention of Chronic Total Occlusion: Single Center, Prospective, Non-Inferior Randomized Controlled Trial and Prospective Observational Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000035646

Enrollment

Unknown

Registered

2020-08-15

Start date

2020-10-01

Completion date

Unknown

Last updated

2020-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery disease

Interventions

Drug-eluting stent group:Drug-eluting stent implantation

Drug-coated balloon group:Drug-coated balloon Dilation

CHIP-CTO Group:Treatment after multidisciplinary team disccusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients were men and women at least 18 years old who presented objective evidence of myocardial ischemia, such as myocardial ischemia or ventricular dysfunction in a territory supplied by CTO. CTO was defined as an occlusive (100% stenosis) coronary lesion with antegrade Thrombolysis In Myocardial Infarction flow grade 0 for at least 3 month. If patients was asymptimatic, noninvasive examinations (ECG exercise test,stress echocardiography, myocardial perfusion imaging, etc) were highly recommended.

Exclusion criteria

Exclusion criteria: 1. Pregnant woman; 2. High risk of hemorrhage or active gastrointestinal ulcer, or stroke or transient ischemic stroke within 6 months, or pateints who were not expected to tolerate 12-month dual antiplatelet therapy after PCI; 3. Malignancies and other comorbid conditions with a life expectancy less than 12 months or other problems leading to difficulties on clinical follow up; 4. Contemporaneous enrollment in a different clinical trial; 5. Other reasons of which the investigator considered the patients unsuitable for inclusion; 6. Patients with no objective evidence of myocardial ischemia or myocardial viability, or very small dominant range of the CTO lesion.

Design outcomes

Primary

Measure	Time frame
Target Lesion Failure;Procedure success rate;Target vessel flow fraction reserve (FFR);	—

Secondary

Measure	Time frame
MACCE (Death, Myocardial Infarction or Stroke);Patient oriented MACCE (Death, Myocardial Infarction or Stroke);Definite or Probable Stent Thrombosis (ST);Other CTO-PCI related complication rate;	—

Countries

China

Contacts

Public ContactLei Ge

Zhongshan Hospital, Fudan University

ge.lei@zs-hospital.sh.cn+86 13816112695

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026