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NCT03521843
LDD in Treatment of Femoropopliteal ISR
NA trial testing balloon dilation only in Peripheral Artery Disease in 40 participants. Status unknown.
30 April 2019
Quick facts
| Lead sponsor | RenJi Hospital |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 1 January 2018 |
| Primary completion | 30 April 2019 |
| Estimated completion | 31 October 2019 |
| Sites | 1 location across China |
Drugs / interventions tested
- balloon dilation only
- balloon dilation+local drug delivery
Conditions studied
- Peripheral Artery Disease — all drugs for Peripheral Artery Disease →
- In-stent Restenosis — all drugs for In-stent Restenosis →
Sponsor
RenJi Hospital
Who can join
Adults 18 to 80, any sex, with Peripheral Artery Disease or In-stent Restenosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will evaluate the effectiveness and safety of local drug delivery using TAPAS balloon catheter system in the treatment of femoropopliteal in-stent restenosis. Patients with femoropopliteal in-stent restenosis will randomly receive balloon dilation or balloon dilation plus local drug delivery using balloon catheter system. Their clinical outcomes (e.g. 12-month late lumen loss or late lumen loss at secondary intervention within 12 months, 6-month and 1-year patency rate of target vessel) in 1 year after the treatment will be compared.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03521843
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other RenJi Hospital trials
Trials by the same sponsor.
- NCT07584733 — Biomarker-Enriched Kidney-Preserving Strategy With Disitamab Vedotin Plus Tislelizumab in HER2-Positive High-Risk Upper · Phase 2 · not yet recruiting
- NCT07537725 — EEG-TMS for Postoperative Delirium After Cardiac Surgery · NA · not yet recruiting
- NCT07527936 — A Study of BEN301 Injection in theTreatment of Autoimmune Diseases · EARLY_PHASE1 · not yet recruiting
- NCT07343076 — Efficacy of Immediate Versus Staged Complete Revascularization in Patients With NSTE-ACS and Multivessel Disease (FUTURE · NA · not yet recruiting
- NCT07449793 — Biochemical Response and Clinical Outcomes in Patients With PBC · recruiting
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 NCT03521843 (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 RenJi Hospital
- Last refreshed: 11 May 2018
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/NCT03521843.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing