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Effectiveness and safety of simultaneous injection contrast (SIC) guiding stents release

Effectiveness and safety of simultaneous injection contrast (SIC) guiding stents release

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-10001449
Enrollment
Unknown
Registered
2010-10-27
Start date
2010-12-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

coronary artery disease

Interventions

Group A: stent apposition in SIC:Be verified in IVUS/OCT. If not, stents were post-expanded
Group B: stent malapposition in SIC,not to increas:Be verified in IVUS/OCT. If so, stents were post-expanded
Group C:Be verified in IVUS/OCT. If so, stents were post-expanded

Sponsors

Beijing An Zhen Hospital, Capital Medical University; Beijing Institute of Heart Lung and Blood Vessel Diseases
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Male or non-pregnant female; 2. Myocardial ischemia (stable, unstable, silent) or old MI; 3. De novo lesions with at least 70% stenosis in QCA; 4. Can be sufficient dilated by pre-dilating balloon; 5. Only one stent was planned in the target lesion; 6. The difference between nearly and distal reference vessel is less than 0.25 mm in diameter; the diameter of nearly reference vessel is less than 3.5mm; 7. No contradictions to CABG.

Exclusion criteria

Exclusion criteria: 1. Acute myocardial infarction within 1 week; 2. Concomitant cardiac valve disease, congenital heart disease requiring surgical therapy; severe heart failure (NYHA>=III grade); left ventricular ejection fraction=2mg/dl); 5. Hemorrhagic tendency; active peptic ulcer; history of hemorrhagic stroke; history of ischemic stroke within 6 months;Any contraindication to antithrombotic therapy; 6. Allergy to contrast; 7. Life expectancy shorter than 12 months; 8. The heart transplant recipients.

Design outcomes

Primary

MeasureTime frame
dissection in coranary artery;stent apposition or malappositio;

Secondary

MeasureTime frame
coronary angiogrphy after 12 months;clinical follow up after 1, 30,180 days and 1 year;

Countries

China

Contacts

Public ContactShuzheng LV
shuzheng@medmail.com.cn+86 10 64456981

Outcome results

None listed

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