Drug Eluting Balloon Angioplasty Versus Nitinol Stent Implantation in the Superficial Femoral Artery

Randomized Controlled Trial of Paclitaxel Drug-coated Balloons vs. Nitinol Stent for Femoropopliteal Obstructions - The PAVENST Trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02212470

Acronym

PAVENST

Enrollment

Registered

2014-08-08

Start date

2014-07-31

Completion date

2019-10-31

Last updated

2021-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial Occlusive Diseases, Arteriosclerosis, Atherosclerosis, Cardiovascular Diseases, Critical Limb Ischemia, Paclitaxel, Peripheral Arterial Disease, Peripheral Vascular Diseases, Plaque, Atherosclerotic

Keywords

Artery, Atherosclerosis, Peripheral, Arterial, Plaque, PTA, Angioplasty, Femoropopliteal, Self Expandable Nitinol Stents

Brief summary

The purpose of this study is to evaluate whether the results of drug eluting balloon are non-inferior to the Nitinol stent implantation in the femoropopliteal segment.

Interventions

DEVICENitinol stenting

Nitinol stent deployment

DEVICEDrug Eluting Balloon Angioplasty

Angioplasty with Drug eluting balloon after pre dilatation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Intervention model description

Prospective, randomized, single-center, single-blind, non-inferiority, clinical trial

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients over 18 years with critical lower limb ischemia, * Ruhtherford 3 or higher, * with angiographic documentation of greater than 70% or occlusion in the superficial femoral artery, * with a maximum extension of 10 cm stenosis. * The popliteal artery and at least one leg artery must be patent.

Exclusion criteria

* Pregnancy, * thrombophilia, * coagulation disorders, * presence of active or recent bleeding, * severe allergy to iodinated contrast, * renal or hepatic disease, * acute limb ischemia, * prior surgical bypass or angioplasty (with or without stent) on the target artery, * obstructive disease (stenosis\> 50%) of the aortoiliac segment ipsilateral to the target (if the aortoiliac is pre-treated, the patient may be included)

Design outcomes

Primary

Measure	Time frame	Description
Primary patency	12 months	Evaluations will be conducted after 3, 6 and 12 months of the procedure. The ultrasonographic evaluation of the degree of stenosis will use the Systolic Velocity Index (division of the velocity of flow at the point of greatest stenosis by the velocity of flow in normal prior segment). Rates higher than 2.4 indicate stenosis greater than 50%

Secondary

Measure	Time frame	Description
Ankle braquial Index	12 months	Change in the Ankle braquial Index evaluated in 3, 6 and 12 months
Target Lesion Revascularization	12 months	Target Lesion Revascularization rate evaluated in 3, 6 and 12 months
Stent fracture	12 months	Stent fracture rate evaluated in 3, 6 and 12 months
Rutherford classification	12 months	Change in classification from Rutherford evaluated in 3, 6 and 12 months.
Acute myocardial infarct	12 months	Acute myocardial infarct rate evaluated in 3, 6 and 12 months
Death	12 months	Death rate evaluated in 3, 6 and 12 months
Amputation	12 months	Major amputation defined as amputation that requires prosthesis

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026