The DES BTK Vascular Stent System vs PTA in Subjects With Critical Limb Ischemia
Public ClinicalTrials.gov record NCT03551496. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Trial Comparing the Drug-Eluting Stent (DES) Below-the-Knee (BTK) Vascular Stent System (DES BTK Vascular Stent System) vs Percutaneous Transluminal Angioplasty (PTA) Treating Infrapopliteal Lesions in Subjects With Critical Limb Ischemia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Single phased global, prospective, multicenter clinical trial designed to demonstrate a superior patency rate and acceptable safety in below the knee arteries with lesions treated with the DES BTK Vascular Stent System vs. percutaneous transluminal angioplasty (PTA).
Study identification
- NCT ID
- NCT03551496
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 201 participants
Conditions and interventions
Conditions
Interventions
- Drug Eluting Stent - Below the Knee Combination Product
- Standard PTA Control Arm Device
Combination Product · Device
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2018 (Actual)
- Primary completion
- Apr 21, 2022 (Actual)
- Completion
- Dec 20, 2023 (Actual)
- Last update posted
- Jul 1, 2024
2018 – 2023
United States locations
- U.S. sites
- 26
- U.S. states
- 17
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| St. Bernards Medical Center | Jonesboro | Arkansas | 72401 | — |
| Arkansas Heart Hospital | Little Rock | Arkansas | 72211 | — |
| University of California, San Francisco | San Francisco | California | 94143 | — |
| Colorado VA | Denver | Colorado | 80220 | — |
| Bradenton Cardiology | Bradenton | Florida | 34205 | — |
| Willis Knighton Bossier Medical Center - Grace Research, LLC | Bossier City | Louisiana | 71111 | — |
| Cardiovascular Institute of the South Clinical Research Corporation | Houma | Louisiana | 70360 | — |
| Advanced Cardiac & Vascular Centers for Amputation Prevention | Grand Rapids | Michigan | 49525 | — |
| United Heart and Vascular Clinic | Saint Paul | Minnesota | 55102 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Holy Name Medical Center | Teaneck | New Jersey | 07666 | — |
| New Mexico Heart Institute, PA | Albuquerque | New Mexico | 87102 | — |
| New York University Medical Center | New York | New York | 10016 | — |
| Mount Sinai Medical Center | New York | New York | 10029 | — |
| Amputation Prevention Center of North Carolina | Cary | North Carolina | 27518 | — |
| NC Heart and Vascular Research, LLC | Raleigh | North Carolina | 27607 | — |
| Wake Medical Center | Raleigh | North Carolina | 27610 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| OhioHealth Research and Innovation Institute - Riverside Methodist Hospital | Columbus | Ohio | 43214 | — |
| Integris Baptist Medical Center | Oklahoma City | Oklahoma | 73112 | — |
| Saint Vincent Consultants in Cardiovascular Diseases at St. Vincent Hospital | Erie | Pennsylvania | 16544 | — |
| Jackson-Madison County General Hospital | Jackson | Tennessee | 38305 | — |
| Heart Hospital of Austin | Austin | Texas | 78756 | — |
| Texas Tech University Health | Lubbock | Texas | 79430 | — |
| THR Presbyterian Plano | Plano | Texas | 75093 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 16 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03551496, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 1, 2024 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03551496 live on ClinicalTrials.gov.