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NCT06879561
Pressure Wire Guidance for Infrapopliteal Artery Interventions
NA trial testing Angiography-guided angioplasty in Chronic Limb-Threatening Ischemia in 100 participants. Currently enrolling.
29 December 2027
Quick facts
| Lead sponsor | Yonsei University |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 2 October 2025 |
| Primary completion | 29 December 2027 |
| Estimated completion | 29 August 2028 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Angiography-guided angioplasty
- Pressure wire-guided angioplasty
Conditions studied
- Chronic Limb-Threatening Ischemia — all drugs for Chronic Limb-Threatening Ischemia →
Sponsor
Yonsei University
Who can join
19 and older, any sex, with Chronic Limb-Threatening Ischemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
"• A prospective, single-center randomized controlled comparison trial. * A total of 100 patients with symptoms of chronic limb-threatening ischemia (Rutherford category 5) undergoing endovascular treatment for anterior tibial artery or posterior tibial artery lesions will be included if they meet the inclusion criteria and do not meet any exclusion criteria. * Patients will be randomized in a 1:1 open-label manner either to the pressure wire-guided group or the angiography-guided group. * Patients will be treated with balloon angioplasty for anetrior tibial artery or posterior tibial artery lesions. * In the angiography-guided group, balloon angioplasty will be performed to achieve an optimal procedural result, as determined by angiography. Optimal results are defined as antegrade blood flow without residual stenosis \>50% or flow-limiting dissection. * In the Pressure Wire-guided gorup, balloon angioplasty will be performed to obtain optimal procedural result based on both angiography and a pressure gradient over the target lesion. Optimal pressure gradient is less than 10 mmHg by measurement using a Pressure Wire. * The primary efficacy endpoint is defined by attaiment of skin perfusion pressure ≥50 mmHg within 1-3 days after the index procedure. * Patients will be followed at 1, 3, and 6 months after the procdure to assess wound healing status, and clinical events."
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06879561
- Europe PMC full search
- ASCO Meeting Library
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Related trials
Other trials of Angiography-guided angioplasty
Trials testing the same drug.
- NCT03517904 — Comparison of Intravascular Ultrasound-Guided vs. Angiography-guided Angioplasty and Dual-antiplatelet v. Triple-antipla · NA · completed
Other recruiting trials for Chronic Limb-Threatening Ischemia
Currently open trials in the same condition.
- NCT07352800 — Safety of Antithrombotic Heparin Proteoglycan Mimetic APAC in Peripheral Arterial Occlusive Disease and Chronic Limb-thr · Phase 2 · recruiting
- NCT06071429 — Bioresorbable Sirolimus-Eluting Scaffold Treatment for Below the Knee Disease · NA · recruiting
- NCT06656364 — Esprit BTK Post-Approval Study · NA · active not recruiting
- NCT07330635 — Chronic Wounds and Blood Circulation Detection · NA · recruiting
- NCT06149650 — Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study · recruiting
Other Yonsei University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06879561 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Yonsei University
- Last refreshed: 2 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06879561.
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