Peripheral Arterial Occlusive DiseaseFINESTNCT01113892

Study Comparing Synthetic Vascular Grafts in Patients With Peripheral Artery Disease (PAD) Who Require Artery Bypass.

A study testing vascular grafts in people with Peripheral Arterial Occlusive Disease, run by Maquet Cardiovascular at 25 sites in 3 countries.

Completed

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

Official record

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Trial summary

To demonstrate the patency and safety of vascular grafts: EXXCEL and FUSION Bioline. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Peripheral Arterial Occlusive Disease
What is being tested?: vascular grafts
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 207 participants
Where: 25 sitesin 3 countries
Study dates: 17 May 2010to 4 Jun 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

Patient required either above-knee or below-knee femoral popliteal bypass;
Patient had Category 1, 2, 3 4 or 5 chronic limb ischemia as defined by the Rutherford Categories - chronic limb ischemia severity classification scale.
Patient was at least 21 years of age;
Patient had postoperative life expectancy of >18 months;
Patient was willing and able to have follow-up visits and examinations;
Patient would not participate in other clinical trials that would conflict with this protocol
Patient was willing and able to provide written, informed consent.

Who cannot join

Patient had a previous history of bypass in the diseased extremity (below the iliacs arteries);
Patient had percutaneous transluminal angioplasty or stenting of the target femoral or popliteal artery at the anticipated site of the proximal or distal anastomosis within the previous 30 days;
Patient had active infection in the region of graft placement;
Patient had an acute arterial occlusion requiring an emergent intervention;
Patient needed a cardiac surgical procedure or a different vascular surgical procedure within 30 days of planned lower extremity revascularization. Planned endovascular procedures to address proximal stenotic lesions at the time of the index femoropopliteal bypass did not exclude a patient from the study;
Patient required sequential extremity revascularizations or other procedures that require use of additional vascular grafts;

Show all 15Show fewer

Patient had known hypersensitivity or contraindication to aspirin;
Patient had known coagulation disorders including hypercoagulability;
Patient had previous instance of heparin-induced thrombocytopenia type 2 or has known hypersensitivity to heparin; Patient was currently treated with Coumadin (warfarin) that had not been stopped within 72 hours of the planned procedure
Patient had severe chronic renal insufficiency (plasma/serum creatinine > 2.5 mg/dl), is undergoing hemodialysis.
Patient had prior renal transplant;
Patient had a stroke or myocardial infarction within 6 weeks of the procedure or had evidence of prior massive stroke (Modified Rankin Scale 3 or above);
Patient had a myocardial infarction within 6 weeks prior to the procedure or had unstable angina pectoris;
Patient had documented acute or suspected systemic infection;
Patient was a woman of reproductive potential.

Trial locations and contacts

25 sites in 3 countries.

Country

City, postcode or hospital

25 sites in 3 countries

United States18 sites

Albany Medical Center
Albany, New York, 12208
University of Alabama-Birmingham Medical Center
Birmingham, Alabama, 35294
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dallas VA Medical Center
Dallas, Texas, 75216
Methodist Hospital
Houston, Texas, 77030
Dartmouth- Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Central Arkansas Veterans Health System
Little Rock, Arkansas, 72205
NYU School of Medicine
New York, New York, 10016
NY Presbyterian Hospital - Columbia Univ Medical Center
New York, New York, 10032
Norfolk Sentara - Norfolk General Hospital
Norfolk, Virginia, 23507
VA Palo Alto HCS
Palo Alto, California, 94304
Swedish Medical Center
Seattle, Washington, 98122
University of South Florida - Tampa General
Tampa, Florida, 33606
Central Texas Veterans Health System
Temple, Texas, 76504
Scott & White
Temple, Texas, 76508
Montefiore Weiler Hospital
The Bronx, New York, 10461
Montefiore Medical Center
The Bronx, New York, 10467

Other trials in United States

Czechia6 sites

Fakulti Nemocnice Brno
Brno, 625 00
Fakultni Nemocnice u sv Anny v Brno
Brno, 656 91
University Hospital Plzen
Pilsen, 304 60
Vseobecna Fakultni Nemocnice (VFN) Praha
Prague, 128 08
IKEM Praha
Prague, 140 21
Nemocnice Na Homolce
Prague, 150 30

Other trials in Czechia

Germany1 site

Klinikum Karlsruhe
Karlsruhe, 76133

Other trials in Germany

About this study

Official title: Comparison of Safety and Primary Patency Between FUSION Vascular Graft With Bioline and EXXCEL Soft ePTFE (FINEST)

To demonstrate the patency and safety of vascular grafts: EXXCEL and FUSION Bioline.

Read the detailed description

The study is a prospective, randomized, single-blind, two-arm, parallel group, multi-center study to evaluate the safety and efficacy of FUSION™ Vascular Graft with Bioline (heparin) coating, compared with EXXCEL Soft ePTFE in a peripheral bypass setting, to support a claim of substantial equivalence.

Conditions: Peripheral Arterial Occlusive Disease
Being tested: vascular grafts
Medical subject headings: Peripheral Arterial Occlusive Disease 1

What participants receive

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

vascular graftsDevice
All devices will be used to treat patients with peripheral arterial occlusive disease

Study groups in NCT01113892
Study group	Role	What they receive
EXXCEL Soft	Active comparator	A vascular graft comprised of extruded, expanded polytetrafluroethylene (ePTFE), indicated for use as a vascular prosthesis for replacement or bypass of diseased peripheral arteries (510(k) K962433). Receives: Device: vascular grafts
FUSION Bioline	Experimental	A synthetic vascular graft constructed of two layers. The inner layer is comprised of extruded, ePTFE. The outer layer is comprised of knit polyester textile. These two layers are fused together with a proprietary polycarbonate-urethane adhesive. The vascular graft also has a heparin coating on the graft's luminal surface. The Bioline coating is a bioactive surface coating consisting of a covalent Heparin Sodium coupled to immobilized recombinant human albumin. Receives: Device: vascular grafts

What is being measured

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

Number of Participants With Primary Patency
A graft was considered to have primary patency if it had remained continuously patent (i.e., had continued blood flow through it) from the time of implantation and it had uninterrupted patency with no procedure performed on it, nor a procedure to address disease progression in the adjacent native vessel. Stenosis developing within the graft without remediation or occlusion was not considered a loss of primary patency. Assessed by duplex ultrasound imaging and ankle brachial index (ABI).
Measured: 6 months
The Number of Participants Meeting Composite Endpoint of Major Adverse Limb Events (MALE) and Periprocedural Death (POD)
The composite endpoint included any of the following:
- Major amputation - amputation that resulted in limb shortening (e.g., proximal to, but not including transmetatarsal amputations);
- Major graft reintervention - placement of a new bypass graft at the same anatomic site, a jump/interposition graft, graft thrombectomy, graft excision, or graft thrombolysis;
- Procedure-related death - any death within 30 days of the index procedure or within 30 days of any remedial procedure performed at the same anatomic site or as a result of the index procedure.
Measured: 6 months

Secondary outcomes (3)

Number of Participants With Primary Assisted Patency
Primary assisted patency was defined as continued patency without thrombosis, with or without an endovascular or open surgical intervention to remediate a stenosis or other disorder of the graft.
Measured: 6 months
Number of Participants With Secondary Patency
Secondary patency was defined as patency after some form of intervention to restore and maintain blood flow after occlusion.
Measured: 6 months
Time to Hemostasis of Suture Hole Bleeding (Min)
Time from the release of clamps until hemostasis, where hemostasis is defined as the absence of detectable bleeding from any of the suture holes.
Measured: Post-procedure

Timeline

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

17 May 20104 Jun 2013

First posted30 Apr 2010 (estimated)
Study start17 May 2010
Primary completion18 Dec 2012
Study completion4 Jun 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Peripheral Arterial Occlusive 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This was a prospective, randomized, single-blind (subject), parallel group, multicenter study in subjects with peripheral arterial occlusive disease (PAOD) who were scheduled to undergo femoral popliteal peripheral bypass surgery. Eligible subjects were randomly assigned in a 1:1 ratio to receive either FUSION Bioline or EXXCEL vascular graft.
Masking: Single blind
Who is masked: Participant
Enrolment: 207 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01113892
Sponsor's protocol ID: MCV00001506
Acronym: FINEST
Status last verified: May 2020
First submitted: 28 Apr 2010
Last updated: 22 May 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Lumsden AB, Morrissey NJ; Comparison of Safety and Primary Patency Between the FUSION BIOLINE Heparin-Coated Vascular Graft and EXXCEL Soft ePTFE (FINEST) Trial Co-investigators. Randomized controlled trial comparing the safety and efficacy between the FUSION BIOLINE heparin-coated vascular graft and the standard expanded polytetrafluoroethylene graft for femoropopliteal bypass. J Vasc Surg. 2015 Mar;61(3):703-12.e1. doi: 10.1016/j.jvs.2014.10.008.
PubMed 25720929
Correia RM, Nakano LC, Vasconcelos V, Cristino MA, Flumignan RL. Prevention of infection in peripheral arterial reconstruction of the lower limb. Cochrane Database Syst Rev. 2025 Oct 29;10(10):CD015022. doi: 10.1002/14651858.CD015022.pub2.
PubMed 41159585

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?

See locations

Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight

All Peripheral Arterial Occlusive Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Safety and Primary Patency Between FUSION Vascular Graft With Bioline and EXXCEL Soft ePTFE (FINEST)
ClinicalTrials.gov ID: NCT01113892
Acronym / sponsor ID: FINEST / MCV00001506
Conditions: Peripheral Arterial Occlusive Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 207 participants (actual)
Lead sponsor: Maquet CardiovascularIndustry (pharma, biotech, devices)
Study start: 17 May 2010 (actual)
Primary completion: 18 Dec 2012 (actual)
Study completion: 4 Jun 2013 (actual)
First posted: 30 Apr 2010 (estimated)
Results: Posted 22 May 2020

Clinical summary

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

To demonstrate the patency and safety of vascular grafts: EXXCEL and FUSION Bioline.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: This was a prospective, randomized, single-blind (subject), parallel group, multicenter study in subjects with peripheral arterial occlusive disease (PAOD) who were scheduled to undergo femoral popliteal peripheral bypass surgery. Eligible subjects were randomly assigned in a 1:1 ratio to receive either FUSION Bioline or EXXCEL vascular graft.

Arm	Type	Receives
EXXCEL Soft	Active comparator	Device: vascular graftsA vascular graft comprised of extruded, expanded polytetrafluroethylene (ePTFE), indicated for use as a vascular prosthesis for replacement or bypass of diseased peripheral arteries (510(k) K962433).
FUSION Bioline	Experimental	Device: vascular graftsA synthetic vascular graft constructed of two layers. The inner layer is comprised of extruded, ePTFE. The outer layer is comprised of knit polyester textile. These two layers are fused together with a proprietary polycarbonate-urethane adhesive. The vascular graft also has a heparin coating on the graft's luminal surface. The Bioline coating is a bioactive surface coating consisting of a covalent Heparin Sodium coupled to immobilized recombinant human albumin.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Patient required either above-knee or below-knee femoral popliteal bypass;
Patient had Category 1, 2, 3 4 or 5 chronic limb ischemia as defined by the Rutherford Categories - chronic limb ischemia severity classification scale.
Patient was at least 21 years of age;
Patient had postoperative life expectancy of >18 months;
Patient was willing and able to have follow-up visits and examinations;

Key exclusion criteria (15 listed)

Patient had a previous history of bypass in the diseased extremity (below the iliacs arteries);
Patient had percutaneous transluminal angioplasty or stenting of the target femoral or popliteal artery at the anticipated site of the proximal or distal anastomosis within the previous 30 days;
Patient had active infection in the region of graft placement;
Patient had an acute arterial occlusion requiring an emergent intervention;
Patient needed a cardiac surgical procedure or a different vascular surgical procedure within 30 days of planned lower extremity revascularization. Planned endovascular procedures to address proximal stenotic lesions at the time of the index femoropopliteal bypass did not exclude a patient from the study;

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
vascular graftsAll devices will be used to treat patients with peripheral arterial occlusive disease	Device	EXXCEL Soft, FUSION Bioline

Primary outcome

Number of Participants With Primary Patency
Time frame: 6 months
A graft was considered to have primary patency if it had remained continuously patent (i.e., had continued blood flow through it) from the time of implantation and it had uninterrupted patency with no procedure performed on it, nor a procedure to address disease progression in the adjacent native vessel. Stenosis developing within the graft without remediation or occlusion was not considered a loss of primary patency. Assessed by duplex ultrasound imaging and ankle brachial index (ABI).
The Number of Participants Meeting Composite Endpoint of Major Adverse Limb Events (MALE) and Periprocedural Death (POD)
Time frame: 6 months
The composite endpoint included any of the following: * Major amputation - amputation that resulted in limb shortening (e.g., proximal to, but not including transmetatarsal amputations); * Major graft reintervention - placement of a new bypass graft at the same anatomic site, a jump/interposition graft, graft thrombectomy, graft excision, or graft thrombolysis; * Procedure-related death - any death within 30 days of the index procedure or within 30 days of any remedial procedure performed at the same anatomic site or as a result of the index procedure.

3 secondary outcomes

Number of Participants With Primary Assisted Patency
Time frame: 6 months
Number of Participants With Secondary Patency
Time frame: 6 months
Time to Hemostasis of Suture Hole Bleeding (Min)
Time frame: Post-procedure

Results and safety

Results posted to the registry on 22 May 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
EXXCEL Soft	101	87
FUSION Bioline	106	90

Primary outcome: Number of Participants With Primary Patency

Time frame: 6 months. Count of participants. Unit: Participants

Measure	EXXCEL Soft n = 100	FUSION Bioline n = 103
Value	70	89

EXXCEL Soft vs FUSION Bioline: Mean Difference (Net): 16.4 (95% CI 2.7 to 29.9), p <.0001, Exact 1-sided test

Population analysed: Subset of the efficacy analysis population with available data for analysis. The efficacy analysis population included all randomized subjects who met a study endpoint at 6 months.

Primary outcome: The Number of Participants Meeting Composite Endpoint of Major Adverse Limb Events (MALE) and Periprocedural Death (POD)

Time frame: 6 months. Count of participants. Unit: Participants

Measure	EXXCEL Soft n = 101	FUSION Bioline n = 105
Major amputation	2	5
Major graft reintervention	31	17
Procedure-related death	1	1
Any MALE or POD	31	18

EXXCEL Soft vs FUSION Bioline: p = .033, Fisher Exact

Population analysed: Safety population, defined as all randomized subjects who received the FUSION Bioline or EXXCEL vascular graft, analyzed according to the treatment they received.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: One Year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
EXXCEL Soft	50 of 101 (49.5%)	14 of 101 (13.9%)	2 of 101
FUSION Bioline	44 of 105 (41.9%)	24 of 105 (22.9%)	4 of 105

Limitations and caveats (from the sponsor): Follow-up period was limited to 12 months. The inner layer is identical to EXXCEL, but FUSION Bioline also has an external polyester layer in addition to the heparin coating. Choices in perioperative care (surgeon discretion) may have differed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25720929Lumsden AB, Morrissey NJ; Comparison of Safety and Primary Patency Between the FUSION BIOLINE Heparin-Coated Vascular Graft and EXXCEL Soft ePTFE (FINEST) Trial Co-investigators. Randomized controlled trial comparing the safety and efficacy between the FUSION BIOLINE heparin-coated vascular graft and the standard expanded polytetrafluoroethylene graft for femoropopliteal bypass. J Vasc Surg. 2015 Mar;61(3):703-12.e1. doi: 10.1016/j.jvs.2014.10.008.
Derived from this study: PubMed 41159585Correia RM, Nakano LC, Vasconcelos V, Cristino MA, Flumignan RL. Prevention of infection in peripheral arterial reconstruction of the lower limb. Cochrane Database Syst Rev. 2025 Oct 29;10(10):CD015022. doi: 10.1002/14651858.CD015022.pub2.
Individual participant dataSharing planned: No

Related trials for Peripheral Arterial Occlusive Disease

Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight

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.

Alan Lumsden, MD principal investigator

The Methodist Hospital Research Institute

Nicholas J. Morrissey, MD principal investigator

NY Presbyterian-Columbia U Medical Center

25 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing vascular grafts in people with Peripheral Arterial Occlusive Disease, run by Maquet Cardiovascular at 25 sites in 3 countries.

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 7 inclusion and 15 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 22 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States, Czechia, Germany. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Primary Patency (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT01113892, which also lists 2 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 22 May 2020.