Trial Outcomes & Findings for Study Comparing Synthetic Vascular Grafts in Patients With Peripheral Artery Disease (PAD) Who Require Artery Bypass. (NCT NCT01113892)

Last Updated: 2020-05-22

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

207 participants

Primary outcome timeframe

6 months

Results posted on

2020-05-22

Participant Flow

Recruitment period was from May 2010 to June 2012 at 18 sites in the United States (US) and 7 sites outside the US.

Subjects (209) were randomly assigned to FUSION Bioline (108) or EXXCEL (101) - 2 subjects in the FUSION Bioline group did not undergo surgery and are excluded from all analysis. One (1) of 207 treated subjects was included in efficacy analysis but excluded from safety analysis due to wrong treatment (FUSION instead of FUSION Bioline implanted).

Participant milestones

Participant milestones
Measure	EXXCEL Soft Patients who were enrolled and treated with the EXXCEL Soft vascular graft.	FUSION Bioline Patients who were enrolled and treated with the FUSION Bioline vascular graft.
Overall Study STARTED	101	106
Overall Study COMPLETED	87	90
Overall Study NOT COMPLETED	14	16

Reasons for withdrawal

Reasons for withdrawal
Measure	EXXCEL Soft Patients who were enrolled and treated with the EXXCEL Soft vascular graft.	FUSION Bioline Patients who were enrolled and treated with the FUSION Bioline vascular graft.
Overall Study Lost to Follow-up	2	2
Overall Study Withdrawal by Subject	1	1
Overall Study Death	2	4
Overall Study Graft no longer evaluable	9	9

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EXXCEL Soft n=100 Participants Patients who were enrolled and treated with the EXXCEL Soft vascular graft.	FUSION Bioline n=103 Participants Patients who were enrolled and treated with the FUSION Bioline vascular graft.	Total n=203 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	59 Participants n=5 Participants	43 Participants n=7 Participants	102 Participants n=5 Participants
Age, Categorical >=65 years	41 Participants n=5 Participants	60 Participants n=7 Participants	101 Participants n=5 Participants
Age, Continuous	63.6 years STANDARD_DEVIATION 8.76 • n=5 Participants	65.7 years STANDARD_DEVIATION 8.57 • n=7 Participants	64.7 years STANDARD_DEVIATION 8.71 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	30 Participants n=7 Participants	58 Participants n=5 Participants
Sex: Female, Male Male	72 Participants n=5 Participants	73 Participants n=7 Participants	145 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	92 Participants n=5 Participants	98 Participants n=7 Participants	190 Participants n=5 Participants
Race/Ethnicity, Customized African American	8 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants	35 participants n=7 Participants	67 participants n=5 Participants
Region of Enrollment Czechia	64 participants n=5 Participants	63 participants n=7 Participants	127 participants n=5 Participants
Region of Enrollment Germany	4 participants n=5 Participants	5 participants n=7 Participants	9 participants n=5 Participants
Weight	83.1 kg STANDARD_DEVIATION 16.96 • n=5 Participants	81.4 kg STANDARD_DEVIATION 17.06 • n=7 Participants	82.2 kg STANDARD_DEVIATION 16.99 • n=5 Participants
Body Mass Index (BMI)	27.8 kg/m^2 STANDARD_DEVIATION 4.85 • n=5 Participants	27.7 kg/m^2 STANDARD_DEVIATION 4.86 • n=7 Participants	27.7 kg/m^2 STANDARD_DEVIATION 4.85 • n=5 Participants
Height	172.5 cm STANDARD_DEVIATION 8.1 • n=5 Participants	171.2 cm STANDARD_DEVIATION 10.2 • n=7 Participants	171.8 cm STANDARD_DEVIATION 9.2 • n=5 Participants
Rutherford Category 1-3 (claudication)	76 Participants n=5 Participants	71 Participants n=7 Participants	147 Participants n=5 Participants
Rutherford Category 4-5 (limb threat)	24 Participants n=5 Participants	32 Participants n=7 Participants	56 Participants n=5 Participants
Ankle Brachial Index (ABI)	0.56 Ratio STANDARD_DEVIATION 0.21 • n=5 Participants	0.55 Ratio STANDARD_DEVIATION 0.24 • n=7 Participants	0.55 Ratio STANDARD_DEVIATION 0.22 • n=5 Participants
Baseline medications Aspirin	85 Participants n=5 Participants	87 Participants n=7 Participants	172 Participants n=5 Participants
Baseline medications Clopidogrel	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Baseline medications Any antiplatelet	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Baseline medications Warfarin	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Baseline medications Statin	62 Participants n=5 Participants	67 Participants n=7 Participants	129 Participants n=5 Participants
Baseline medications Angiotensin-converting enzyme (ACE) inhibitor	91 Participants n=5 Participants	81 Participants n=7 Participants	172 Participants n=5 Participants
Comorbidities Previous target limb intervention	29 Participants n=5 Participants	22 Participants n=7 Participants	51 Participants n=5 Participants
Comorbidities Hyperlipidemia/hypercholesterolemia	72 Participants n=5 Participants	71 Participants n=7 Participants	143 Participants n=5 Participants
Comorbidities Hypertension	90 Participants n=5 Participants	84 Participants n=7 Participants	174 Participants n=5 Participants
Comorbidities Coronary artery disease	35 Participants n=5 Participants	38 Participants n=7 Participants	73 Participants n=5 Participants
Comorbidities Obesity	27 Participants n=5 Participants	25 Participants n=7 Participants	52 Participants n=5 Participants
Comorbidities Chronic obstructive lung disease	16 Participants n=5 Participants	24 Participants n=7 Participants	40 Participants n=5 Participants
Comorbidities Cerebrovascular event	12 Participants n=5 Participants	7 Participants n=7 Participants	19 Participants n=5 Participants
Comorbidities Liver disease	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Comorbidities Bleeding disorder	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Comorbidities Renal failure/dysfunction	3 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants
Comorbidities Diabetes mellitus	34 Participants n=5 Participants	38 Participants n=7 Participants	72 Participants n=5 Participants
Comorbidities Previous myocardial infarction	22 Participants n=5 Participants	21 Participants n=7 Participants	43 Participants n=5 Participants
Comorbidities Arrhythmia	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Comorbidities Congestive heart failure	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Comorbidities Varicose veins	17 Participants n=5 Participants	20 Participants n=7 Participants	37 Participants n=5 Participants
Tobacco use Current smoker	51 Participants n=5 Participants	54 Participants n=7 Participants	105 Participants n=5 Participants
Tobacco use Prior smoker	32 Participants n=5 Participants	31 Participants n=7 Participants	63 Participants n=5 Participants
Tobacco use Non-smoker	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants
Graft diameter 6 mm	49 Participants n=5 Participants	48 Participants n=7 Participants	97 Participants n=5 Participants
Graft diameter 8 mm	51 Participants n=5 Participants	55 Participants n=7 Participants	106 Participants n=5 Participants
Leg treated Right	47 Participants n=5 Participants	50 Participants n=7 Participants	97 Participants n=5 Participants
Leg treated Left	53 Participants n=5 Participants	53 Participants n=7 Participants	106 Participants n=5 Participants
Site of proximal anastomosis External iliac	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Site of proximal anastomosis Common femoral	94 Participants n=5 Participants	99 Participants n=7 Participants	193 Participants n=5 Participants
Site of proximal anastomosis Profunda femoral	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Site of proximal anastomosis Superficial femoral	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Site of proximal anastomosis Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Site of distal anastomosis Above knee	86 Participants n=5 Participants	88 Participants n=7 Participants	174 Participants n=5 Participants
Site of distal anastomosis Below knee	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Site of distal anastomosis Other	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 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.

Outcome measures

Outcome measures
Measure	EXXCEL Soft n=100 Participants Patients who were enrolled and treated with the EXXCEL Soft vascular graft.	FUSION Bioline n=103 Participants Patients who were enrolled and treated with the FUSION Bioline vascular graft.
Number of Participants With Primary Patency	70 Participants	89 Participants

PRIMARY outcome

Timeframe: 6 months

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

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.

Outcome measures

Outcome measures
Measure	EXXCEL Soft n=101 Participants Patients who were enrolled and treated with the EXXCEL Soft vascular graft.	FUSION Bioline n=105 Participants Patients who were enrolled and treated with the FUSION Bioline vascular graft.
The Number of Participants Meeting Composite Endpoint of Major Adverse Limb Events (MALE) and Periprocedural Death (POD) Major amputation	2 Participants	5 Participants
The Number of Participants Meeting Composite Endpoint of Major Adverse Limb Events (MALE) and Periprocedural Death (POD) Major graft reintervention	31 Participants	17 Participants
The Number of Participants Meeting Composite Endpoint of Major Adverse Limb Events (MALE) and Periprocedural Death (POD) Procedure-related death	1 Participants	1 Participants
The Number of Participants Meeting Composite Endpoint of Major Adverse Limb Events (MALE) and Periprocedural Death (POD) Any MALE or POD	31 Participants	18 Participants

SECONDARY outcome

Timeframe: 6 months

Population: 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 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.

Outcome measures

Outcome measures
Measure	EXXCEL Soft n=100 Participants Patients who were enrolled and treated with the EXXCEL Soft vascular graft.	FUSION Bioline n=103 Participants Patients who were enrolled and treated with the FUSION Bioline vascular graft.
Number of Participants With Primary Assisted Patency	73 Participants	89 Participants

SECONDARY outcome

Timeframe: 6 months

Population: 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.

Secondary patency was defined as patency after some form of intervention to restore and maintain blood flow after occlusion.

Outcome measures

Outcome measures
Measure	EXXCEL Soft n=99 Participants Patients who were enrolled and treated with the EXXCEL Soft vascular graft.	FUSION Bioline n=103 Participants Patients who were enrolled and treated with the FUSION Bioline vascular graft.
Number of Participants With Secondary Patency	80 Participants	91 Participants

SECONDARY outcome

Timeframe: Post-procedure

Population: 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.

Time from the release of clamps until hemostasis, where hemostasis is defined as the absence of detectable bleeding from any of the suture holes.

Outcome measures

Outcome measures
Measure	EXXCEL Soft n=100 Participants Patients who were enrolled and treated with the EXXCEL Soft vascular graft.	FUSION Bioline n=102 Participants Patients who were enrolled and treated with the FUSION Bioline vascular graft.
Time to Hemostasis of Suture Hole Bleeding (Min)	11 minutes Standard Deviation 10.63	3.5 minutes Standard Deviation 4.72

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days

Population: 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.

Outcome measures

Outcome measures
Measure	EXXCEL Soft n=99 Participants Patients who were enrolled and treated with the EXXCEL Soft vascular graft.	FUSION Bioline n=101 Participants Patients who were enrolled and treated with the FUSION Bioline vascular graft.
Number of Participants With Primary Patency	87 Participants	96 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: 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. The 12 month efficacy analysis population for the 12 month results included those subjects who met the study endpoint at both 6 and 12 months.

Outcome measures

Outcome measures
Measure	EXXCEL Soft n=97 Participants Patients who were enrolled and treated with the EXXCEL Soft vascular graft.	FUSION Bioline n=98 Participants Patients who were enrolled and treated with the FUSION Bioline vascular graft.
Number of Participants With Primary Patency	65 Participants	75 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days

Population: 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 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.

Outcome measures

Outcome measures
Measure	EXXCEL Soft n=99 Participants Patients who were enrolled and treated with the EXXCEL Soft vascular graft.	FUSION Bioline n=101 Participants Patients who were enrolled and treated with the FUSION Bioline vascular graft.
Number of Participants With Primary Assisted Patency	87 Participants	96 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

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.

Outcome measures

Outcome measures
Measure	EXXCEL Soft n=97 Participants Patients who were enrolled and treated with the EXXCEL Soft vascular graft.	FUSION Bioline n=98 Participants Patients who were enrolled and treated with the FUSION Bioline vascular graft.
Number of Participants With Primary Assisted Patency	67 Participants	76 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days

Population: 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.

Secondary patency was defined as patency after some form of intervention to restore and maintain blood flow after occlusion.

Outcome measures

Outcome measures
Measure	EXXCEL Soft n=99 Participants Patients who were enrolled and treated with the EXXCEL Soft vascular graft.	FUSION Bioline n=101 Participants Patients who were enrolled and treated with the FUSION Bioline vascular graft.
Number of Participants With Secondary Patency	92 Participants	97 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Secondary patency was defined as patency after some form of intervention to restore and maintain blood flow after occlusion.

Outcome measures

Outcome measures
Measure	EXXCEL Soft n=95 Participants Patients who were enrolled and treated with the EXXCEL Soft vascular graft.	FUSION Bioline n=96 Participants Patients who were enrolled and treated with the FUSION Bioline vascular graft.
Number of Participants With Secondary Patency	77 Participants	80 Participants

Adverse Events

EXXCEL Soft

Serious events: 50 serious events

Other events: 14 other events

Deaths: 2 deaths

FUSION Bioline

Serious events: 44 serious events

Other events: 24 other events

Deaths: 4 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	EXXCEL Soft n=101 participants at risk Patients who were enrolled and treated with the EXXCEL Soft vascular graft. The safety population was defined as all randomized subjects who received the FUSION Bioline or EXXCEL vascular graft, analyzed according to the treatment they received.	FUSION Bioline n=105 participants at risk Patients who were enrolled and treated with the FUSION Bioline vascular graft. The safety population was defined as all randomized subjects who received the FUSION Bioline or EXXCEL vascular graft, analyzed according to the treatment they received. Note that one patient was randomized to the Fusion Bioline group but received the FUSION graft in error.
Injury, poisoning and procedural complications Anaemia postoperative	5.9% 6/101 • Number of events 6 • One Year An adverse event was defined as any side effect associated with the treatment procedure or device that produced an untoward medical effect or that had adverse health implications for the subject receiving the treatment. Adverse event data were collected from the time of procedure start through the last follow-up visit. Note that one (1) of 207 treated subjects was included in efficacy analysis but excluded from safety analysis due to wrong treatment (FUSION instead of FUSION Bioline implanted).	10.5% 11/105 • Number of events 12 • One Year An adverse event was defined as any side effect associated with the treatment procedure or device that produced an untoward medical effect or that had adverse health implications for the subject receiving the treatment. Adverse event data were collected from the time of procedure start through the last follow-up visit. Note that one (1) of 207 treated subjects was included in efficacy analysis but excluded from safety analysis due to wrong treatment (FUSION instead of FUSION Bioline implanted).
General disorders Oedema peripheral	8.9% 9/101 • Number of events 9 • One Year An adverse event was defined as any side effect associated with the treatment procedure or device that produced an untoward medical effect or that had adverse health implications for the subject receiving the treatment. Adverse event data were collected from the time of procedure start through the last follow-up visit. Note that one (1) of 207 treated subjects was included in efficacy analysis but excluded from safety analysis due to wrong treatment (FUSION instead of FUSION Bioline implanted).	10.5% 11/105 • Number of events 11 • One Year An adverse event was defined as any side effect associated with the treatment procedure or device that produced an untoward medical effect or that had adverse health implications for the subject receiving the treatment. Adverse event data were collected from the time of procedure start through the last follow-up visit. Note that one (1) of 207 treated subjects was included in efficacy analysis but excluded from safety analysis due to wrong treatment (FUSION instead of FUSION Bioline implanted).
General disorders Impaired healing	2.0% 2/101 • Number of events 2 • One Year An adverse event was defined as any side effect associated with the treatment procedure or device that produced an untoward medical effect or that had adverse health implications for the subject receiving the treatment. Adverse event data were collected from the time of procedure start through the last follow-up visit. Note that one (1) of 207 treated subjects was included in efficacy analysis but excluded from safety analysis due to wrong treatment (FUSION instead of FUSION Bioline implanted).	5.7% 6/105 • Number of events 6 • One Year An adverse event was defined as any side effect associated with the treatment procedure or device that produced an untoward medical effect or that had adverse health implications for the subject receiving the treatment. Adverse event data were collected from the time of procedure start through the last follow-up visit. Note that one (1) of 207 treated subjects was included in efficacy analysis but excluded from safety analysis due to wrong treatment (FUSION instead of FUSION Bioline implanted).

Additional Information

Elizabeth Bulger

Getinge Group

Phone: 603 880 1433

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The publication or presentation of the results from a single site was not allowed until the preparation and publication of the multi-center results. Individual sites could publish or present information, provided that a draft was given to the sponsor for review and comment for a period that is at least 60 days prior to the first date of submission to allow the sponsor to review its content for accuracy, confidential information or patentable inventions.
Publication restrictions are in place

Restriction type: OTHER