Trial · NCT04765566
FLUENCY® PLUS in the Treatment of Peripheral Artery Disease
NCT04765566, Completed, C. R. Bard
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. FLUENCY® PLUS in the Treatment of Peripheral Artery Disease. Trials, record NCT04765566. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04765566
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- FLUENCY® PLUS in the Treatment of Peripheral Artery Disease
- NCT number
- NCT04765566
- Status
- Completed
- Enrollment
- 146 participants, actual
- Lead sponsor
- C. R. Bard
- Conditions
- Vascular Diseases, Peripheral
- Interventions
- Endovascular revascularization of peripheral arteries
- First posted
- 2021-02-21
- Last updated
- 2022-04-29
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Freedom from major complications | 30 days | Freedom from device- and/or procedure-related death or myocardial infarction (MI), or any Target Lesion Revascularization (TLR), or target limb major amputation (above the ankle) through 30 days following the index procedure. |
| Primary | Target Lesion Revascularization | 12 months | Target Lesion Revascularization (TLR) through 12-months post-index procedure. |
| Secondary | Technical Success | During Procedure | Proportions of lesions with technical success. Technical success is defined as the successful treatment of the target lesion at the index procedure using the FLUENCY® PLUS Vascular Stent Graft, as reported in the questionnaire by the Investigator. |
| Secondary | Procedural Success | From Procedure until patient is discharged from hospital (average of 2 days) | Proportions of patients with technical success and no peri-procedural complications (death, stroke, myocardial infarction (MI), emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel) prior to hospital discharge. |
| Secondary | Target Lesion Revascularization | 24 months, 36 months, 60 months | Target Lesion Revascularization (TLR) through 24 (if applicable)-, 36 (if applicable)-, and 60 (if applicable)-months post-index procedure. |
| Secondary | Target Vessel Revascularization | 12 months, 24 months, 36 months, 60 months | Target Vessel Revascularization (TVR) through 12-, 24 (if applicable)-,36 (if applicable) and 60 (if applicable)-months post-index procedure. TVR is defined as the first revascularization procedure (e.g. PTA, stenting, surgical bypass, etc.) in the target vessel segment following the index procedure. |
| Secondary | Sustained Clinical Success | 30 days, 12 months, 24 months, 36 months, 60 months | Proportions of patients with sustained cumulative improvement from baseline value of ≥ 1 Rutherford Category at 30-days and 12-, 24 (if applicable)-, 36 (if applicable) and 60 (if applicable)-months post-index procedure, as determined by the Investigator. |
| Secondary | Primary Patency | 12 months, 24 months, 36 months, 60 months | Primary Patency at 12-, 24 (if applicable)-, 36 (if applicable)- and 60 (if applicable)- months post-index procedure (freedom from TLR and restenosis). Restenosis will be assessed by duplex ultrasonography (DUS) or angiography and is present when the target lesion is determined to have \>50% stenosis, as determined by the Investigator. |
| Secondary | Puncture site complications | From Procedure until patient is discharged from hospital (average of 2 days) | Presence of peri procedural complications and/or significant post-operative hematoma at puncture site, as determined by the Investigator. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04765566
GET https://conductscience.org/api/trials/v1/NCT04765566/registered