Who is sponsoring NCT03552289?

NCT03552289 is sponsored by Cook Research Incorporated.

What condition does NCT03552289 study?

NCT03552289 studies End-Stage Renal Disease.

Is NCT03552289 still recruiting?

NCT03552289 is currently completed. Last updated 19 October 2020.

Are results published for NCT03552289?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-10-19 · How we verify

NCT03552289

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Cook Enforcer Post-Market Study

Completed NA Results posted Last updated 19 October 2020

What this trial tests

NA trial testing Cook Advance® Enforcer 35 Focal-Force Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter in End-Stage Renal Disease in 211 participants. Completed in 27 August 2019.

Timeline

7 August 2018

Primary endpoint
29 May 2019

27 August 2019

Quick facts

Lead sponsor	Cook Research Incorporated
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	211
Start date	7 August 2018
Primary completion	29 May 2019
Estimated completion	27 August 2019
Sites	5 locations across United States

Drugs / interventions tested

Cook Advance® Enforcer 35 Focal-Force Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
Conventional angioplasty balloon catheters

Conditions studied

End-Stage Renal Disease — all drugs for End-Stage Renal Disease →

Sponsor

Cook Research Incorporated — full company profile →

Who can join

18 and older, any sex, with End-Stage Renal Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent of Lesions Requiring Adjunctive Treatment Primary · Immediately following treatment of stenoses of a mature native arteriovenous dialysis access circuit fistula or graft, up to approximately 1 hour

Percentage of lesions requiring adjunctive treatment immediately following the initial treatment with the Enforcer or conventional angioplasty balloon

Group	Value	95% CI
Cook Enforcer Balloon Catheter	30
Conventional Angioplasty Balloon Catheters	26

Adverse events — posted to ClinicalTrials.gov

Time frame: 90 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cook Enforcer Balloon Catheter

Serious: 2/102 (2%)

Deaths: 1/102

Conventional Angioplasty Balloon Catheters

Serious: 1/109 (1%)

Deaths: 2/109

Serious adverse events (4 terms)

Reaction	System	Cook Enforcer Balloon Cath…	Conventional Angioplasty B…
Right Femur Fracture after fall	Injury, poisoning and procedural complications	—	—
Diabetic ulcer of lower extremity	Skin and subcutaneous tissue disorders	—	—
Head injury s/p fall	Injury, poisoning and procedural complications	—	—
Septic Shock	Infections and infestations	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	Cook Enforcer Balloon Cath…	Conventional Angioplasty B…
Restenosis or occlusion	Vascular disorders	—	—
Thrombosis	Vascular disorders	—	—

Most-reported serious reactions: Right Femur Fracture after fall, Diabetic ulcer of lower extremity, Head injury s/p fall, Septic Shock.

Data from ClinicalTrials.gov NCT03552289 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the performance of the Cook Advance® Enforcer™ 35 Focal-Force PTA Balloon Catheter (or Enforcer balloon) in treating narrowed blood vessels compared to treatment with a conventional angioplasty balloon.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Vessel Preparation Is Essential to Optimize Endovascular Therapy of Infrainguinal Lesions.
Saucy F, Probst H, Trunfio R. · · 2020 · cited 4× · PMID 33173787 · DOI 10.3389/fcvm.2020.558129

Verify or expand the search:

Other recruiting trials for End-Stage Renal Disease

Currently open trials in the same condition.

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Other Cook Research Incorporated trials

Trials by the same sponsor.

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NCT06358001 — EchoTip AcuCore Post-Market Clinical Study · completed
NCT06094127 — Zenith Thoracic Alpha (ZTA) Post-Market Data Collection · active not recruiting
NCT05182255 — Post Market Clinical Study - Evolution® Esophageal Stent Systems, Europe: Fully and Partially Covered · completed
NCT04635228 — Biodesign® Otologic Repair Graft · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03552289 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Cook Research Incorporated
Last refreshed: 19 October 2020

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/NCT03552289.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing