Trial Outcomes & Findings for The Pathway PVD Study for Percutaneous Peripheral Vascular Interventions (NCT NCT00676494)

Results Overview

Major adverse events (MAEs) are any death, target vessel revascularization (TVR), target lesion revascularization (TLR), myocardial infarction (MI), or amputation of the treated limb that occurred within 30 days of the index procedure.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

172 participants

Primary outcome timeframe

30 days

Results posted on

2009-07-09

Participant Flow

Participant milestones

Participant milestones
Measure	All Patients Patients meeting eligibility criteria and enrolled in the study.
Overall Study STARTED	172
Overall Study COMPLETED	158
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Reasons for withdrawal
Measure	All Patients Patients meeting eligibility criteria and enrolled in the study.
Overall Study Missed Visit	8
Overall Study Withdrawal by Subject	6

Baseline Characteristics

The Pathway PVD Study for Percutaneous Peripheral Vascular Interventions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Patients n=172 Participants Patients meeting eligibility criteria and enrolled in the study.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	38 Participants n=5 Participants
Age, Categorical >=65 years	134 Participants n=5 Participants
Age Continuous	71.9 years STANDARD_DEVIATION 8.4 • n=5 Participants
Sex: Female, Male Female	88 Participants n=5 Participants
Sex: Female, Male Male	84 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Population: Number of study participants was statistically determined by protocol-defined endpoints. Analysis endpoints were assessed via summary statistics and 95% confidence intervals. No p-values were generated and no statistical inferences asserted regarding point estimates or confidence limits generated for any additional post-hoc data analysis.

Major adverse events (MAEs) are any death, target vessel revascularization (TVR), target lesion revascularization (TLR), myocardial infarction (MI), or amputation of the treated limb that occurred within 30 days of the index procedure.

Outcome measures

Outcome measures
Measure	All Patients n=172 Participants Patients meeting eligibility criteria and enrolled in the study.
Major Adverse Events (MAEs) Within 30 Days	2 Participants

SECONDARY outcome

Timeframe: 6 months

Population: Number of study participants was statistically determined by protocol-defined endpoints. Analysis endpoints were assessed via summary statistics and 95% confidence intervals. No p-values were generated and no statistical inferences asserted regarding point estimates or confidence limits generated for any additional post-hoc data analysis.

Rutherford Classification measures lower limb peripheral arterial disease (PAD) by evaluating and rating symptoms. Score: 0 (no symptoms or discomfort in leg) to 6 (Tissue loss or gangrene in leg)

Outcome measures

Outcome measures
Measure	All Patients n=135 Participants Patients meeting eligibility criteria and enrolled in the study.
Average Rutherford Classification Score at 6 Months	1.5 Score on scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: 6 months

Population: Number of study participants was statistically determined by protocol-defined endpoints. Analysis endpoints were assessed via summary statistics and 95% confidence intervals. No p-values were generated and no statistical inferences asserted regarding point estimates or confidence limits generated for any additional post-hoc data analysis.

Ankle Brachial Index (ABI) is the ratio of the blood pressure in the lower legs to the blood pressure in the arms. Compared to the arm, lower blood pressure in the leg is a symptom of peripheral artery disease (PAD). Range: Normal arteries (1.0 - 1.2) to Severe arterial disease (under 0.5)

Outcome measures

Outcome measures
Measure	All Patients n=138 Participants Patients meeting eligibility criteria and enrolled in the study.
Average Ankle Brachial Index (ABI) at 6 Months	0.77 units on scale Standard Deviation 0.26

SECONDARY outcome

Timeframe: 6 months

Population: Number of study participants was statistically determined by protocol-defined endpoints. Analysis endpoints were assessed via summary statistics and 95% confidence intervals. No p-values were generated and no statistical inferences asserted regarding point estimates or confidence limits generated for any additional post-hoc data analysis.

Number of patients that did not require target lesion revascularization 6 months after index procedure.

Outcome measures

Outcome measures
Measure	All Patients n=172 Participants Patients meeting eligibility criteria and enrolled in the study.
Freedom From Target Lesion Revascularization (TLR) at 6 Months	147 participants

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kevin Peters/Director of Clinical Affairs

Pathway Medical Technologies, Inc.

Phone: 425-636-4053

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Investigators will have the right to publish results of the Study, provided that Investigators submit copies of any proposed publication to Sponsor for review at least 30 days and up to 60 days in advance of publication. Sponsor may extend such review period for another 90 days to file patent applications or protect its Related Rights.
Publication restrictions are in place

Restriction type: OTHER