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A Prospective Randomized Controlled Trial for assessment of Short-term and Long-term Effects of Medication and Eluting Stent in the Treatment of Angiographic Borderline Stenosis

A Prospective Randomized Control Trial: comparing of Clinical Short-term and Long-term Effects of Angiographic Borderline Stenosis Treatment with Medicine or Drug Eluting Stent (RCT-EAST)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-07000008
Enrollment
Unknown
Registered
2007-01-23
Start date
2007-01-01
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

stable angina

Interventions

PCI group:stenting with CYPHER DES, combined with loading dosage of antiplatelet agents at least 1 year (according to international standard) and intensive lipid-lowing therapy (according to the inter
medication group:the same treatment protocol as PCI group on antiplatelet treatment and intensive lipid-lowing therapy

Sponsors

Cardiovascular Institute & Fuwai Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Males and no pregnancy women who older than 18 and younger than 75; 2. Patients with stable angina; 3. Coronary arteriography shows that diameter stenosis of de novo lesion is from 50 to 70 percent by visual; 4. Target artery calibre >2.25mm <4.0mm; 5. The minimum lumen from 3.8mm2 to 4.8mm2 detected by intravascular ultrasound (IVUS).

Exclusion criteria

Exclusion criteria: 1. Bifurcation, coronary artery bypass graft, restenosis, severe calcification and left main coronary artery lesions; 2. The sign of plaque rupture, such as partial filling defect indicate thrombosis, or contrast medium retention, ulcer lesion; 3. Patients with acute coronary syndrome; 4. According to borderline lesion which has been infarction-related artery or multi-vessele borderline lesion; 5. The minimum lumen area is less than 3.8mm2 undergoing IVUS measurement will rule out, but PCI should perform; 6. Patient with central neural organic disease; 7. Patient with severe renal or liver function deficiency; 8. Be sensitive to or a confirmed history of intolerance to aspirin or clopidogrel; 9. Patient with malignant tumors.

Design outcomes

Primary

MeasureTime frame
index of lumen and plaque by QCA and IVUS;Rate of TLR, TVR, Restenosis and Thrombosis;Rate of Major Adverse Cardiac Event (MACE) at different time point;

Countries

China

Contacts

Public ContactChen Jilin
jilin.chen@263.net+86 010 88398044

Outcome results

None listed

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