Skip to content

Comparison of provisional T-stent with or without branch ostial optimization techniques for treatment of coronary bifurcation lesions: The PTOOT Phase-I Trial

Comparison of provisional T-stent with or without branch ostial optimization techniques for treatment of coronary bifurcation lesions

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023463
Enrollment
Unknown
Registered
2019-05-29
Start date
2019-07-01
Completion date
Unknown
Last updated
2019-06-03

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

Conditions

cardiovascular disease

Interventions

1:Branch Ostial Optimization Techniques
2:without OOT

Sponsors

Fujian Medical University, Union Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged > 18 and = 80 year; 2. Patients with stable angina, unstable angina or non-ST elevation myocardial infarction; 3. Patients with de novo coronary bifurcation lesions (Medina 0,1,11,1,11,0,1) and the diameter of the main branch = 2.5 mm and the side-branch = 2.25 mm by visually angiographic estimation 4. Lesions suitable to PCI (for instance, left main bifurcated lesion with SYNTAX score = 32), and suitable to 2-stent implantation as necessary; 5. Patients willing to participating and following up; 6. Patients (or legal guardian) understanding the trial protocol and requirement with written consent.

Exclusion criteria

Exclusion criteria: 1. Lesions unsuitable to 2-stent implantation (for instances, chronic total occlusion with either of branches unable to recanalization, severely calcified bifurcation lesion requiring rotablation, or the side-branch 700 × 10^9/L, white count5 URL)or renal dysfunction (eGRF<30ml/min/1.73m2), congestive heart failure (NYHA= III) etc. 6. Severe illness with life expectance of less 12 months, for instances, cancers, other end-stage deceases; 7. Women with or planning to pregnancy; 8. Patients with contraindications or allergies to the stent platforms or the associated medications, for instances, stent eluting drugs, stainless steel or alloy, aspirin, P2Y12 inhibitors, contrast agents, etc.; 9. Patients participating another drug or instrument ongoing trial, or planning to participate another drug or instrument trial within 12 month post-procedurally.

Design outcomes

Primary

MeasureTime frame
1. The rate of the target lesion failure (TLF);

Countries

China

Contacts

Public ContactChen Lianglong

Fujian Medical University, Union Hospital

lianglongchen@126.com+86 13365910021

Outcome results

None listed

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