Peripheral Arterial DiseasePhase 4PAVENSTNCT02212470

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

A Phase 4 study testing Drug Eluting Balloon Angioplasty and Nitinol stenting in people with Peripheral Arterial Disease and Arterial Occlusive Diseases, run by Instituto Dante Pazzanese de Cardiologia at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Peripheral Arterial Disease, Arterial Occlusive Diseases, Atherosclerosis
What is being tested?: Drug Eluting Balloon Angioplasty and Nitinol stenting
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 85 participants
Where: 1 siteBrazil
Study dates: Jul 2014to Oct 2019
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

Pregnancy,
thrombophilia,
coagulation disorders,
presence of active or recent bleeding,
severe allergy to iodinated contrast,
renal or hepatic disease,

Show all 9Show fewer

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)

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Instituto Dante Pazzanese de Cardiologia
São Paulo, 04012909

Other trials in Brazil

About this study

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

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.

Conditions: Peripheral Arterial Disease, Arterial Occlusive Diseases, Atherosclerosis, Arteriosclerosis, Cardiovascular Diseases, Peripheral Vascular Diseases
Being tested: Drug Eluting Balloon Angioplasty, Nitinol stenting
Keywords: Artery, Atherosclerosis, Peripheral, Arterial, Plaque, PTA, Angioplasty, Femoropopliteal, Self Expandable Nitinol Stents
Medical subject headings: Peripheral Arterial Disease, Arterial Occlusive Diseases, Atherosclerosis, Arteriosclerosis, Cardiovascular Diseases, Peripheral Vascular Diseases, Plaque, Atherosclerotic, Chronic Limb-Threatening Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Drug Eluting Balloon AngioplastyDevice
Also called Medtronic, Admiral In.Pact
Angioplasty with Drug eluting balloon after pre dilatation
Nitinol stentingDevice
Also called Medtronic, Complete SE
Nitinol stent deployment

Study groups in NCT02212470
Study group	Role	What they receive
Drug Eluting Balloon	Active comparator	Admiral In.Pact Drug Eluting Balloon Receives: Device: Drug Eluting Balloon Angioplasty
Nitinol Stent	Active comparator	Complete SE Self-expandible Nitinol stent Receives: Device: Nitinol stenting

What is being measured

The primary outcome is the main question the study is designed to answer.

Primary patency
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%
Measured: 12 months

Secondary outcomes (7)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2014Oct 2019

First posted8 Aug 2014 (estimated)
Study startJul 2014
Primary completionDec 2018
Study completionOct 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (27)Papers the sponsor has linked to this study.
Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Prospective, randomized, single-center, single-blind, non-inferiority, clinical trial
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 85 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02212470
Sponsor's protocol ID: IDPC_3 2014
Acronym: PAVENST
Status last verified: Jun 2021
First submitted: 6 Aug 2014
Last updated: 10 Jun 2021
Results posted: No
Data monitoring committee: Yes

Publications

Schillinger M, Sabeti S, Dick P, Amighi J, Mlekusch W, Schlager O, Loewe C, Cejna M, Lammer J, Minar E. Sustained benefit at 2 years of primary femoropopliteal stenting compared with balloon angioplasty with optional stenting. Circulation. 2007 May 29;115(21):2745-9. doi: 10.1161/CIRCULATIONAHA.107.688341. Epub 2007 May 14.
PubMed 17502568
Bosiers M, Torsello G, Gissler HM, Ruef J, Muller-Hulsbeck S, Jahnke T, Peeters P, Daenens K, Lammer J, Schroe H, Mathias K, Koppensteiner R, Vermassen F, Scheinert D. Nitinol stent implantation in long superficial femoral artery lesions: 12-month results of the DURABILITY I study. J Endovasc Ther. 2009 Jun;16(3):261-9. doi: 10.1583/08-2676.1.
PubMed 19642788
Dick P, Wallner H, Sabeti S, Loewe C, Mlekusch W, Lammer J, Koppensteiner R, Minar E, Schillinger M. Balloon angioplasty versus stenting with nitinol stents in intermediate length superficial femoral artery lesions. Catheter Cardiovasc Interv. 2009 Dec 1;74(7):1090-5. doi: 10.1002/ccd.22128.
PubMed 19859954
Laird JR, Katzen BT, Scheinert D, Lammer J, Carpenter J, Buchbinder M, Dave R, Ansel G, Lansky A, Cristea E, Collins TJ, Goldstein J, Cao AY, Jaff MR; RESILIENT Investigators. Nitinol stent implantation vs. balloon angioplasty for lesions in the superficial femoral and proximal popliteal arteries of patients with claudication: three-year follow-up from the RESILIENT randomized trial. J Endovasc Ther. 2012 Feb;19(1):1-9. doi: 10.1583/11-3627.1.
PubMed 22313193
Kawamura Y, Ishii H, Aoyama T, Tanaka M, Takahashi H, Kumada Y, Toriyama T, Murohara T. Nitinol stenting improves primary patency of the superficial femoral artery after percutaneous transluminal angioplasty in hemodialysis patients: a propensity-matched analysis. J Vasc Surg. 2009 Nov;50(5):1057-62. doi: 10.1016/j.jvs.2009.07.017. Epub 2009 Sep 26.
PubMed 19782527
Nguyen BN, Conrad MF, Guest JM, Hackney L, Patel VI, Kwolek CJ, Cambria RP. Late outcomes of balloon angioplasty and angioplasty with selective stenting for superficial femoral-popliteal disease are equivalent. J Vasc Surg. 2011 Oct;54(4):1051-1057.e1. doi: 10.1016/j.jvs.2011.03.283. Epub 2011 Jun 2.
PubMed 21636240
Kasapis C, Henke PK, Chetcuti SJ, Koenig GC, Rectenwald JE, Krishnamurthy VN, Grossman PM, Gurm HS. Routine stent implantation vs. percutaneous transluminal angioplasty in femoropopliteal artery disease: a meta-analysis of randomized controlled trials. Eur Heart J. 2009 Jan;30(1):44-55. doi: 10.1093/eurheartj/ehn514. Epub 2008 Nov 21.
PubMed 19028778
Mwipatayi BP, Hockings A, Hofmann M, Garbowski M, Sieunarine K. Balloon angioplasty compared with stenting for treatment of femoropopliteal occlusive disease: a meta-analysis. J Vasc Surg. 2008 Feb;47(2):461-9. doi: 10.1016/j.jvs.2007.07.059. Epub 2007 Oct 22.
PubMed 17950563
Krankenberg H, Schluter M, Steinkamp HJ, Burgelin K, Scheinert D, Schulte KL, Minar E, Peeters P, Bosiers M, Tepe G, Reimers B, Mahler F, Tubler T, Zeller T. Nitinol stent implantation versus percutaneous transluminal angioplasty in superficial femoral artery lesions up to 10 cm in length: the femoral artery stenting trial (FAST). Circulation. 2007 Jul 17;116(3):285-92. doi: 10.1161/CIRCULATIONAHA.107.689141. Epub 2007 Jun 25.
PubMed 17592075
Serruys PW, Kutryk MJ, Ong AT. Coronary-artery stents. N Engl J Med. 2006 Feb 2;354(5):483-95. doi: 10.1056/NEJMra051091. No abstract available.
PubMed 16452560
Lammer J, Bosiers M, Zeller T, Schillinger M, Boone E, Zaugg MJ, Verta P, Peng L, Gao X, Schwartz LB. First clinical trial of nitinol self-expanding everolimus-eluting stent implantation for peripheral arterial occlusive disease. J Vasc Surg. 2011 Aug;54(2):394-401. doi: 10.1016/j.jvs.2011.01.047. Epub 2011 Jun 12.
PubMed 21658885
Dake MD, Scheinert D, Tepe G, Tessarek J, Fanelli F, Bosiers M, Ruhlmann C, Kavteladze Z, Lottes AE, Ragheb AO, Zeller T; Zilver PTX Single-Arm Study Investigators. Nitinol stents with polymer-free paclitaxel coating for lesions in the superficial femoral and popliteal arteries above the knee: twelve-month safety and effectiveness results from the Zilver PTX single-arm clinical study. J Endovasc Ther. 2011 Oct;18(5):613-23. doi: 10.1583/11-3560.1.
PubMed 21992630
Duda SH, Bosiers M, Lammer J, Scheinert D, Zeller T, Tielbeek A, Anderson J, Wiesinger B, Tepe G, Lansky A, Mudde C, Tielemans H, Beregi JP. Sirolimus-eluting versus bare nitinol stent for obstructive superficial femoral artery disease: the SIROCCO II trial. J Vasc Interv Radiol. 2005 Mar;16(3):331-8. doi: 10.1097/01.RVI.0000151260.74519.CA.
PubMed 15758128
Duda SH, Bosiers M, Lammer J, Scheinert D, Zeller T, Oliva V, Tielbeek A, Anderson J, Wiesinger B, Tepe G, Lansky A, Jaff MR, Mudde C, Tielemans H, Beregi JP. Drug-eluting and bare nitinol stents for the treatment of atherosclerotic lesions in the superficial femoral artery: long-term results from the SIROCCO trial. J Endovasc Ther. 2006 Dec;13(6):701-10. doi: 10.1583/05-1704.1.
PubMed 17154704
Werk M, Langner S, Reinkensmeier B, Boettcher HF, Tepe G, Dietz U, Hosten N, Hamm B, Speck U, Ricke J. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation. 2008 Sep 23;118(13):1358-65. doi: 10.1161/CIRCULATIONAHA.107.735985. Epub 2008 Sep 8.
PubMed 18779447

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Controlled Trial of Paclitaxel Drug-coated Balloons vs. Nitinol Stent for Femoropopliteal Obstructions - The PAVENST Trial
ClinicalTrials.gov ID: NCT02212470
Acronym / sponsor ID: PAVENST / IDPC_3 2014
Conditions: Peripheral Arterial Disease, Arterial Occlusive Diseases, Atherosclerosis, Arteriosclerosis, Cardiovascular Diseases, Peripheral Vascular Diseases
Keywords: Artery, Atherosclerosis, Peripheral, Arterial, Plaque, PTA, Angioplasty, Femoropopliteal
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 85 participants (actual)
Lead sponsor: Instituto Dante Pazzanese de CardiologiaUniversity, hospital or other
Collaborators: Medtronic
Study start: Jul 2014 (actual)
Primary completion: Dec 2018 (actual)
Study completion: Oct 2019 (actual)
First posted: 8 Aug 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: Prospective, randomized, single-center, single-blind, non-inferiority, clinical trial

Arm	Type	Receives
Drug Eluting Balloon	Active comparator	Device: Drug Eluting Balloon AngioplastyAdmiral In.Pact Drug Eluting Balloon
Nitinol Stent	Active comparator	Device: Nitinol stentingComplete SE Self-expandible Nitinol stent

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (9 listed)

Pregnancy,
thrombophilia,
coagulation disorders,
presence of active or recent bleeding,
severe allergy to iodinated contrast,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Drug Eluting Balloon AngioplastyAlso: Medtronic, Admiral In.PactAngioplasty with Drug eluting balloon after pre dilatation	Device	Drug Eluting Balloon
Nitinol stentingAlso: Medtronic, Complete SENitinol stent deployment	Device	Nitinol Stent

Primary outcome

Primary patency
Time frame: 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%

7 secondary outcomes

Rutherford classification
Time frame: 12 months
Ankle braquial Index
Time frame: 12 months
Target Lesion Revascularization
Time frame: 12 months
Stent fracture
Time frame: 12 months
Amputation
Time frame: 12 months
Acute myocardial infarct
Time frame: 12 months
Death
Time frame: 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
Background: PubMed 17502568Schillinger M, Sabeti S, Dick P, Amighi J, Mlekusch W, Schlager O, Loewe C, Cejna M, Lammer J, Minar E. Sustained benefit at 2 years of primary femoropopliteal stenting compared with balloon angioplasty with optional stenting. Circulation. 2007 May 29;115(21):2745-9. doi: 10.1161/CIRCULATIONAHA.107.688341. Epub 2007 May 14.
Background: PubMed 19642788Bosiers M, Torsello G, Gissler HM, Ruef J, Muller-Hulsbeck S, Jahnke T, Peeters P, Daenens K, Lammer J, Schroe H, Mathias K, Koppensteiner R, Vermassen F, Scheinert D. Nitinol stent implantation in long superficial femoral artery lesions: 12-month results of the DURABILITY I study. J Endovasc Ther. 2009 Jun;16(3):261-9. doi: 10.1583/08-2676.1.
Background: PubMed 19859954Dick P, Wallner H, Sabeti S, Loewe C, Mlekusch W, Lammer J, Koppensteiner R, Minar E, Schillinger M. Balloon angioplasty versus stenting with nitinol stents in intermediate length superficial femoral artery lesions. Catheter Cardiovasc Interv. 2009 Dec 1;74(7):1090-5. doi: 10.1002/ccd.22128.
Background: PubMed 22313193Laird JR, Katzen BT, Scheinert D, Lammer J, Carpenter J, Buchbinder M, Dave R, Ansel G, Lansky A, Cristea E, Collins TJ, Goldstein J, Cao AY, Jaff MR; RESILIENT Investigators. Nitinol stent implantation vs. balloon angioplasty for lesions in the superficial femoral and proximal popliteal arteries of patients with claudication: three-year follow-up from the RESILIENT randomized trial. J Endovasc Ther. 2012 Feb;19(1):1-9. doi: 10.1583/11-3627.1.
Background: PubMed 19782527Kawamura Y, Ishii H, Aoyama T, Tanaka M, Takahashi H, Kumada Y, Toriyama T, Murohara T. Nitinol stenting improves primary patency of the superficial femoral artery after percutaneous transluminal angioplasty in hemodialysis patients: a propensity-matched analysis. J Vasc Surg. 2009 Nov;50(5):1057-62. doi: 10.1016/j.jvs.2009.07.017. Epub 2009 Sep 26.
Background: PubMed 21636240Nguyen BN, Conrad MF, Guest JM, Hackney L, Patel VI, Kwolek CJ, Cambria RP. Late outcomes of balloon angioplasty and angioplasty with selective stenting for superficial femoral-popliteal disease are equivalent. J Vasc Surg. 2011 Oct;54(4):1051-1057.e1. doi: 10.1016/j.jvs.2011.03.283. Epub 2011 Jun 2.
Background: PubMed 19028778Kasapis C, Henke PK, Chetcuti SJ, Koenig GC, Rectenwald JE, Krishnamurthy VN, Grossman PM, Gurm HS. Routine stent implantation vs. percutaneous transluminal angioplasty in femoropopliteal artery disease: a meta-analysis of randomized controlled trials. Eur Heart J. 2009 Jan;30(1):44-55. doi: 10.1093/eurheartj/ehn514. Epub 2008 Nov 21.
Background: PubMed 17950563Mwipatayi BP, Hockings A, Hofmann M, Garbowski M, Sieunarine K. Balloon angioplasty compared with stenting for treatment of femoropopliteal occlusive disease: a meta-analysis. J Vasc Surg. 2008 Feb;47(2):461-9. doi: 10.1016/j.jvs.2007.07.059. Epub 2007 Oct 22.
Background: PubMed 17592075Krankenberg H, Schluter M, Steinkamp HJ, Burgelin K, Scheinert D, Schulte KL, Minar E, Peeters P, Bosiers M, Tepe G, Reimers B, Mahler F, Tubler T, Zeller T. Nitinol stent implantation versus percutaneous transluminal angioplasty in superficial femoral artery lesions up to 10 cm in length: the femoral artery stenting trial (FAST). Circulation. 2007 Jul 17;116(3):285-92. doi: 10.1161/CIRCULATIONAHA.107.689141. Epub 2007 Jun 25.
Background: PubMed 16452560Serruys PW, Kutryk MJ, Ong AT. Coronary-artery stents. N Engl J Med. 2006 Feb 2;354(5):483-95. doi: 10.1056/NEJMra051091. No abstract available.
Background: PubMed 21658885Lammer J, Bosiers M, Zeller T, Schillinger M, Boone E, Zaugg MJ, Verta P, Peng L, Gao X, Schwartz LB. First clinical trial of nitinol self-expanding everolimus-eluting stent implantation for peripheral arterial occlusive disease. J Vasc Surg. 2011 Aug;54(2):394-401. doi: 10.1016/j.jvs.2011.01.047. Epub 2011 Jun 12.
Background: PubMed 21992630Dake MD, Scheinert D, Tepe G, Tessarek J, Fanelli F, Bosiers M, Ruhlmann C, Kavteladze Z, Lottes AE, Ragheb AO, Zeller T; Zilver PTX Single-Arm Study Investigators. Nitinol stents with polymer-free paclitaxel coating for lesions in the superficial femoral and popliteal arteries above the knee: twelve-month safety and effectiveness results from the Zilver PTX single-arm clinical study. J Endovasc Ther. 2011 Oct;18(5):613-23. doi: 10.1583/11-3560.1.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

BRUNO L ALMEIDA, MD principal investigator

Instituto Dante Pazzanese de Cardiologia

FABIO H ROSSI, MD, PHD study director

Instituto Dante Pazzanese de Cardiologia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary patency (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02212470, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2021.