Who is sponsoring NCT01680835?

NCT01680835 is sponsored by Medtronic Endovascular.

What drugs are being tested in NCT01680835?

Interventions in NCT01680835: EverFlex™ Self-Expanding Peripheral Stent System.

What condition does NCT01680835 study?

NCT01680835 studies Peripheral Arterial Disease, Lower Extremity Arterial Disease.

Is NCT01680835 still recruiting?

NCT01680835 is currently completed. Last updated 26 December 2019.

Are results published for NCT01680835?

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

Last reviewed 2019-12-26 · How we verify

NCT01680835: DURABILITY PAS

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

EverFlex Post Approval Study

Completed NA Results posted Last updated 26 December 2019

What this trial tests

NA trial testing EverFlex™ Self-Expanding Peripheral Stent System in Peripheral Arterial Disease in 108 participants. Completed in 4 February 2019.

Timeline

14 January 2013

Primary endpoint
23 October 2018

4 February 2019

Quick facts

Lead sponsor	Medtronic Endovascular
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	108
Start date	14 January 2013
Primary completion	23 October 2018
Estimated completion	4 February 2019
Sites	23 locations across United States

Drugs / interventions tested

EverFlex™ Self-Expanding Peripheral Stent System

Conditions studied

Peripheral Arterial Disease — all drugs for Peripheral Arterial Disease →
Lower Extremity Arterial Disease — all drugs for Lower Extremity Arterial Disease →

Sponsor

Medtronic Endovascular — full company profile →

Who can join

18 and older, any sex, with Peripheral Arterial Disease or Lower Extremity Arterial 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.

Primary Outcome - Freedom From Acute Death, Freedom From 36-month Amputation, and Freedom From 36-month Clinically-driven Target Lesion Revascularization Primary · 3 Years

Composite endpoint defined as freedom from acute death, freedom from 36-month amputation, and freedom from 36-month clinically-driven target lesion revascularization compared to a PTA performance goal.

Subjects experiencing safety composite at 1 Year

Group	Value	95% CI
Study Cohort	15

Subjects experiencing safety composite at 2 Years

Group	Value	95% CI
Study Cohort	23

Subjects experiencing safety composite at 3 Years

Group	Value	95% CI
Study Cohort	24

Secondary Outcome - Freedom From Stent Fracture Secondary · 1, 2 and 3 years

Determined by x-ray at 1, 2 and 3 years using the following classifications: Class 0 - No strut fractures Class I - Single tine fracture Class II - Multiple tine fractures Class III - Stent fracture(s) with preserved alignment of the components Class IV - Stent fracture(s) with mal-alignment of the components Class V - Stent fracture(s) in a trans-axial spiral configuration AND the following categories: Category A - Restenosis ≤ 50% at site of fracture Category B - Restenosis ≥ 50% at site of fracture Category C - Occlusion at site of fracture Category D - Unable to determine

Stent Fracture at 1 Year

Group	Value	95% CI
Study Cohort	0

Stent Fracture at 2 Years

Group	Value	95% CI
Study Cohort	1

Stent Fracture at 3 Years

Group	Value	95% CI
Study Cohort	3

Secondary Outcome - Freedom From Acute Death, Freedom From Amputation and Freedom From Clinically-driven Target Lesion Revascularization at 1 and 2 Years Secondary · 1 and 2 years

Defined as the absence of all-cause mortality occurring within 30-days, absence of any major amputation within 12-/24- months and the absence of any clinically-driven repeat invasive procedure, including angioplasty, stenting, endarterectomy, bypass, or thrombolysis, performed to open or increase the lumen diameter inside or within 10 mm of the previously treated lesion due to the return of clinical symptoms within 12-/24- months of the procedure.

Subjects experiencing safety composite at 1 Year

Group	Value	95% CI
Study Cohort	15

Subjects experiencing safety composite at 2 Years

Group	Value	95% CI
Study Cohort	23

Secondary Outcome - Freedom From 36-month Amputation Secondary · 3 Years

Defined as the absence of any major amputation (removal of the target limb or a part of the target limb above the metatarsal line) within 36 months of the procedure.

Subjects with major amputation within 1 Year

Group	Value	95% CI
Study Cohort	0

Subjects with major amputation within 2 Years

Group	Value	95% CI
Study Cohort	1

Subjects with major amputation within 3 Years

Group	Value	95% CI
Study Cohort	1

Secondary Outcome - Freedom From 36-month Clinically-driven Target Lesion Revascularization Secondary · 3 Years

Defined as the absence of any clinically-driven repeat invasive procedure, including angioplasty, stenting, endarterectomy, bypass, or thrombolysis, performed to open or increase the lumen diameter inside or within 10 mm of the previously treated lesion due to the return of clinical symptoms within 36 months of the procedure.

Subjects experiencing CD-TLR within 1 Year

Group	Value	95% CI
Study Cohort	15

Subjects experiencing CD-TLR within 2 Years

Group	Value	95% CI
Study Cohort	22

Subjects experiencing CD-TLR within 3 Years

Group	Value	95% CI
Study Cohort	23

Secondary Outcome - Number of Participants Free From Acute Death Secondary · 30 days

Defined as the absence of all-cause mortality occurring within 30 days of the procedure.

Group	Value	95% CI
Study Cohort	108

Secondary Outcome - Number of Successfully Implanted Stents Secondary · At procedure

Defined as the ability to deploy the stent as intended at the treatment site.

Group	Value	95% CI
Study Cohort	118

Secondary Outcome - Number of Participants With Improvement in Rutherford Clinical Category at 1 Year Secondary · 1 Year

Defined as an improvement in clinical status indicated by a decrease of one or more in Rutherford Clinical Category compared to baseline.

Group	Value	95% CI
Study Cohort	88

Secondary Outcome - Number of Participants With Improvement in Ankle-Brachial Index at 1 Year Secondary · 1 Year

Defined as an increase in the ankle-brachial index (ABI) compared to baseline in subjects with compressible arteries and baseline ABI \< 0.9.

Group	Value	95% CI
Study Cohort	62

Secondary Outcome - Change in Score of Walking Impairment Questionnaire at 1 Year Secondary · 1 Year

Defined as an increase in Walking Impairment Questionnaire score in subjects who did not have iliac disease treated at the time of the index procedure compared to baseline Scale Range: Minimum score 0 to maximum score 100 Higher values represent better outcomes

Change from Baseline Score for pain aching cramp

Group	Value	95% CI
Study Cohort	30.42	± 41.70

Change from Baseline Walking Distance Score

Group	Value	95% CI
Study Cohort	28.08	± 39.37

Change from Baseline Walking Speed Score

Group	Value	95% CI
Study Cohort	21.77	± 33.20

Change from Baseline Stair Climbing Score

Group	Value	95% CI
Study Cohort	21.83	± 36.05

Secondary Outcome - Number of Adverse Events Secondary · 3 Years

Number of Adverse Events in the study through 3 Years.

Group	Value	95% CI
Study Cohort	206

Adverse events — posted to ClinicalTrials.gov

Time frame: 36 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Study Cohort

Serious: 66/108 (61%)

Deaths: 8/108

Serious adverse events (75 terms)

Reaction	System	Study Cohort
Stenosis	General disorders	—
Restenosis	Injury, poisoning and procedural complications	—
Intermittent claudication	Vascular disorders	—
Acute myocardial infarction	Cardiac disorders	—
Angina pectoris	Cardiac disorders	—
Gastrointestinal haemorrhage	Gastrointestinal disorders	—
Anaemia	Blood and lymphatic system disorders	—
Cardiac failure congestive	Cardiac disorders	—
Artery dissection	Vascular disorders	—
Death	General disorders	—
Vascular stent thrombosis	General disorders	—
Arrhythmia	Cardiac disorders	—
Coronary artery disease	Cardiac disorders	—
Pneumonia	Infections and infestations	—
Vascular access site haematoma	Injury, poisoning and procedural complications	—
Cerebrovascular accident	Nervous system disorders	—
Peripheral ischaemia	Vascular disorders	—
Gangrene	Infections and infestations	—
Urinary tract infection	Infections and infestations	—
Hip fracture	Injury, poisoning and procedural complications	—
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Carotid artery stenosis	Nervous system disorders	—
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	—
Cardio-respiratory arrest	Cardiac disorders	—
Inguinal hernia	Gastrointestinal disorders	—

Most-reported serious reactions: Stenosis, Restenosis, Intermittent claudication, Acute myocardial infarction, Angina pectoris, Gastrointestinal haemorrhage, Anaemia, Cardiac failure congestive.

Data from ClinicalTrials.gov NCT01680835 adverse events section.

Sponsor's own description

This post-approval study is designed to confirm the long-term safety and effectiveness of the EverFlex™ Self-Expanding Stent System for the treatment of atherosclerotic superficial femoral artery (SFA) and proximal popliteal 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:

Other recruiting trials for Peripheral Arterial Disease

Currently open trials in the same condition.

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NCT07427108 — Road Mapping Guided Puncture Versus Ultrasound Guided Puncture During Retrograde Angioplasty Feasibility and Safety · NA · recruiting
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 Medtronic Endovascular trials

Trials by the same sponsor.

NCT04484220 — Ellipsys Vascular Access System Post Market Surveillance (PS) Study · NA · completed
NCT03820947 — VenaSeal Spectrum: Global Post-Market Randomized Controlled Trial · NA · terminated
NCT04494035 — AVATR - Arteriovenous Access Thrombosis Removal With CAPERE Thrombectomy System · NA · terminated
NCT04120610 — FlowMet-R Blood Flow Measurement for the Diagnosis of Peripheral Artery Disease and Critical Limb Ischemia · terminated
NCT03869645 — CAPERE Thrombectomy System Post-Market Clinical Follow Up Study · terminated

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 NCT01680835 (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 Medtronic Endovascular
Last refreshed: 26 December 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/NCT01680835.

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