Last reviewed · How we verify
NCT03271710: ENTRAP
Study to Evaluate the Lower Extremity Intervention With Integrated Embolic Protection Using the Vanguard IEP System
NA trial testing peripheral balloon angioplasty in Peripheral Arterial Disease in 113 participants. Completed in 30 December 2018.
30 November 2018
Quick facts
| Lead sponsor | Contego Medical, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 113 |
| Start date | 1 September 2017 |
| Primary completion | 30 November 2018 |
| Estimated completion | 30 December 2018 |
| Sites | 9 locations across Belgium, Germany |
Drugs / interventions tested
- peripheral balloon angioplasty
Conditions studied
- Peripheral Arterial Disease — all drugs for Peripheral Arterial Disease →
- Intermittent Claudication — all drugs for Intermittent Claudication →
- Atherosclerosis of Femoral Artery — all drugs for Atherosclerosis of Femoral Artery →
Sponsor
Contego Medical, Inc. — full company profile →
Who can join
18 and older, any sex, with Peripheral Arterial Disease or Intermittent Claudication. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The ENTRAP Study is a prospective, multi-center, non-randomized, single-arm, study with follow-up to 30 days to determine the acute safety, acute device performance and clinical performance of the Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection. The Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection is indicated for peripheral vascular percutaneous transluminal angioplasty (PTA) and capture and removal of embolic material during angioplasty for the femoral, iliac, popliteal and profunda arteries.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03271710
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Peripheral Arterial Disease
Currently open trials in the same condition.
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- NCT07336381 — Replexa+ Shortwave Diathermy Device for Patients Diagnosed With Peripheral Artery Disease and Peripheral Neuropathy · NA · recruiting
- NCT07076082 — Vascular Trial Associated Registry Pilot · Phase 4 · recruiting
- NCT06308562 — Fuzzy Wale Compression Stockinet to Promote Healing Following Transtibial Amputation for Peripheral Arterial Disease · NA · recruiting
Other Contego Medical, Inc. trials
Trials by the same sponsor.
- NCT05845710 — Direct Access Carotid Artery Stenting Using the Neuroguard IEP System (PERFORMANCE III) · NA · completed
- NCT04142541 — Evaluation of the 3-in-1 Neuroguard IEP System for Carotid Artery Stenosis · NA · completed
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 NCT03271710 (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 Contego Medical, Inc.
- Last refreshed: 10 July 2019
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/NCT03271710.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing