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The limb salvage PAteNcy rate after Directional Atherectomy combined with drug-coated balloon angioplasty in lower extremities

The limb salvage PAteNcy rate after Directional Atherectomy combined with drug-coated balloon angioplasty in lower extremities

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900022239
Enrollment
Unknown
Registered
2019-03-31
Start date
2019-04-16
Completion date
Unknown
Last updated
2019-04-01

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

Conditions

peripheral artery disease

Interventions

Case series:Atherectomy, drug Coated balloon dilatation

Sponsors

Beijing Tsinghua Changgung Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: (1) aged between 18 and 90 years; (2) patients with peripheral artery disease (PAD) and Rutherford grade between 3 and 5; (3) de novo and/or secondary moderate-severe stenosis (?50%) or total occlusion lesions in infrainguinal artery which is TASC II type A/B/C; (4) the subject understands the trial content and signs Informed Consent Form before the start of the trial.

Exclusion criteria

Exclusion criteria: (1) patients with acute thrombosis requiring thrombolysis and thrombectomy; (2) patients with known allergic history of anti-platelet drugs, anticoagulants, contrast agents, paclitaxel and others; (3) patients who have participated in other clinical trials of drugs or other medical devices that may interfere this clinical trials within the past 3 months; (4) pregnant and lactating woman; (5) patients with bleeding tendency, coagulation dysfunction and hypercoagulability; (6) patients with other diseases that may lead to test difficulties or significantly shorten life expectancy (<2 years), tumor, liver disease, cardiac insufficiency and other diseases which cause life expectancy is less than 6 months; (7) patients who are unable or unwilling to participate in this study.

Design outcomes

Primary

MeasureTime frame
12-month patency rate;

Countries

China

Contacts

Public ContactWeiwei Wu

Beijing Tsinghua Changgung Hospital

pumcweiwei@126.com+86 13426397036

Outcome results

None listed

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