Trial Outcomes & Findings for Endovascular Denervation Improves Limb Ischemia in Patients With Peripheral Artery Disease (NCT NCT04060797)

NCT ID: NCT04060797

Last Updated: 2024-05-20

Results Overview

The change value was using the ankle brachial index (ABI) at 6-month post-procedure minus the baseline ABI in two group. (the group which have higher change value mean the better result). "Ankle Brachial Index (ABI) is the ratio of the blood pressure in the lower legs to the blood pressure in the arms. The normal range for the ankle-brachial index is between 0.90 and 1.30. An index of 0.41 to 0.90 indicates mild to moderate arterial disease and an index of 0.40 and lower indicates severe disease.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 38 participants
• Primary outcome timeframe: From baseline to 6 months post procedure
• Results posted on: 2024-05-20

Participant Flow

Participant milestones

Measure	The Control Group Treating with balloon dilation or stent implantation only, PTA: Treating with balloon dilation or stent implantation which were Percutaneous transluminal angioplasty (PTA)	The EDN Group Treating with (Endovascular Denervation) EDN at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation. endovascular denervation: Treating with endovascular denervation (EDN) at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation PTA: Treating with balloon dilation or stent implantation which were Percutaneous transluminal angioplasty (PTA)
Overall Study STARTED	19	19
Overall Study COMPLETED	19	19
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Endovascular Denervation Improves Limb Ischemia in Patients With Peripheral Artery Disease

Baseline characteristics by cohort

Measure	The Control Group n=19 Participants Treating with balloon dilation or stent implantation only, PTA: Treating with balloon dilation or stent implantation which were Percutaneous transluminal angioplasty (PTA)	The EDN Group n=19 Participants Treating with (Endovascular Denervation) EDN at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation. endovascular denervation: Treating with endovascular denervation (EDN) at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation PTA: Treating with balloon dilation or stent implantation which were Percutaneous transluminal angioplasty (PTA)	Total n=38 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	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants	15 Participants n=7 Participants	27 Participants n=5 Participants
Age, Continuous	67.53 years STANDARD_DEVIATION 5.55 • n=5 Participants	68.95 years STANDARD_DEVIATION 6.76 • n=7 Participants	68.24 years STANDARD_DEVIATION 6.14 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	16 Participants n=7 Participants	33 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment China	19 participants n=5 Participants	19 participants n=7 Participants	38 participants n=5 Participants
Weight	67.95 Kg STANDARD_DEVIATION 9.59 • n=5 Participants	68.37 Kg STANDARD_DEVIATION 5.34 • n=7 Participants	68.15 Kg STANDARD_DEVIATION 7.76 • n=5 Participants

PRIMARY outcome

Timeframe: From baseline to 6 months post procedure

The change value was using the ankle brachial index (ABI) at 6-month post-procedure minus the baseline ABI in two group. (the group which have higher change value mean the better result).

"Ankle Brachial Index (ABI) is the ratio of the blood pressure in the lower legs to the blood pressure in the arms. The normal range for the ankle-brachial index is between 0.90 and 1.30. An index of 0.41 to 0.90 indicates mild to moderate arterial disease and an index of 0.40 and lower indicates severe disease.

Outcome measures

Measure	The EDN Group n=19 Participants Treating with (Endovascular Denervation) EDN at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation. endovascular denervation: Treating with endovascular denervation (EDN) at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation PTA: Treating with balloon dilation or stent implantation which were Percutaneous transluminal angioplasty (PTA)	The Control Group n=19 Participants Treating with balloon dilation or stent implantation only, PTA: Treating with balloon dilation or stent implantation which were Percutaneous transluminal angioplasty (PTA)
Change of Ankle Brachial Index (ABI) at 6-month Post-procedure.	0.44 ratio Standard Deviation 0.30	0.24 ratio Standard Deviation 0.15

SECONDARY outcome

Timeframe: From baseline to 3 months post procedure

The change value was using the ankle brachial index (ABI) at 3-month post-procedure minus the baseline ABI in two group. (the group which have higher change value mean the better result) "Ankle Brachial Index (ABI) is the ratio of the blood pressure in the lower legs to the blood pressure in the arms. The normal range for the ankle-brachial index is between 0.90 and 1.30. An index of 0.41 to 0.90 indicates mild to moderate arterial disease and an index of 0.40 and lower indicates severe disease.

Outcome measures

Measure	The EDN Group n=19 Participants Treating with (Endovascular Denervation) EDN at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation. endovascular denervation: Treating with endovascular denervation (EDN) at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation PTA: Treating with balloon dilation or stent implantation which were Percutaneous transluminal angioplasty (PTA)	The Control Group n=19 Participants Treating with balloon dilation or stent implantation only, PTA: Treating with balloon dilation or stent implantation which were Percutaneous transluminal angioplasty (PTA)
Change of Ankle Brachial Index (ABI) at 3-month Post-procedure.	0.48 ratio Standard Deviation 0.31	0.28 ratio Standard Deviation 0.19

SECONDARY outcome

Timeframe: From baseline to 1 week post procedure

The change value was using the ankle brachial index (ABI) at 1-week post-procedure minus the baseline ABI in two group. (the group which have higher change value mean the better result) "Ankle Brachial Index (ABI) is the ratio of the blood pressure in the lower legs to the blood pressure in the arms. The normal range for the ankle-brachial index is between 0.90 and 1.30. An index of 0.41 to 0.90 indicates mild to moderate arterial disease and an index of 0.40 and lower indicates severe disease.

Outcome measures

Measure	The EDN Group n=19 Participants Treating with (Endovascular Denervation) EDN at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation. endovascular denervation: Treating with endovascular denervation (EDN) at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation PTA: Treating with balloon dilation or stent implantation which were Percutaneous transluminal angioplasty (PTA)	The Control Group n=19 Participants Treating with balloon dilation or stent implantation only, PTA: Treating with balloon dilation or stent implantation which were Percutaneous transluminal angioplasty (PTA)
Change of Ankle Brachial Index (ABI) at 1-week Post-procedure.	0.28 ratio Standard Deviation 0.33	0.21 ratio Standard Deviation 0.20

SECONDARY outcome

Timeframe: From baseline to 6 months post procedure

Use the Transcutaneous oxygen pressure (TcPO2) at 6-month post-procedure minus the baseline TcPO2.(the higher the value, the better the results)

Outcome measures

Measure	The EDN Group n=19 Participants Treating with (Endovascular Denervation) EDN at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation. endovascular denervation: Treating with endovascular denervation (EDN) at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation PTA: Treating with balloon dilation or stent implantation which were Percutaneous transluminal angioplasty (PTA)	The Control Group n=19 Participants Treating with balloon dilation or stent implantation only, PTA: Treating with balloon dilation or stent implantation which were Percutaneous transluminal angioplasty (PTA)
Change of Transcutaneous Oxygen Pressure (TcPO2)	15.68 mmHg Standard Deviation 16.72	4.95 mmHg Standard Deviation 13.43

SECONDARY outcome

Timeframe: From baseline to 3 months post procedure

Use the Transcutaneous oxygen pressure (TcPO2) at 3-month post-procedure minus the baseline TcPO2.(the higher the value, the better the results)

Outcome measures

Measure	The EDN Group n=19 Participants Treating with (Endovascular Denervation) EDN at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation. endovascular denervation: Treating with endovascular denervation (EDN) at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation PTA: Treating with balloon dilation or stent implantation which were Percutaneous transluminal angioplasty (PTA)	The Control Group n=19 Participants Treating with balloon dilation or stent implantation only, PTA: Treating with balloon dilation or stent implantation which were Percutaneous transluminal angioplasty (PTA)
Change of Transcutaneous Oxygen Pressure (TcPO2)	15.68 mmHg Standard Deviation 15.82	5.58 mmHg Standard Deviation 15.67

SECONDARY outcome

Timeframe: From baseline to 1 week post procedure

Use the Transcutaneous oxygen pressure (TcPO2) at 1 week post-procedure minus the baseline TcPO2.(the higher the value, the better the results)

Outcome measures

Measure	The EDN Group n=19 Participants Treating with (Endovascular Denervation) EDN at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation. endovascular denervation: Treating with endovascular denervation (EDN) at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation PTA: Treating with balloon dilation or stent implantation which were Percutaneous transluminal angioplasty (PTA)	The Control Group n=19 Participants Treating with balloon dilation or stent implantation only, PTA: Treating with balloon dilation or stent implantation which were Percutaneous transluminal angioplasty (PTA)
Change of Transcutaneous Oxygen Pressure (TcPO2)	7.12 mmHg Standard Deviation 15.90	5.16 mmHg Standard Deviation 16.93

SECONDARY outcome

Timeframe: At 6 months post procedure

Number of Subjects with a decrease in Rutherford Category in 6 months (Rutherford category includes a total of 0-6 grades, grade 0 was asymptomatic, grade 1 was mild intermittent claudication, grade 2 was moderate intermittent claudication, grade 3 was severe intermittent claudication, grade 4 was resting pain, grade 5 was minor tissue defect, grade 6 was tissue ulcer, gangrene. The lower the grade, the better the results)

Outcome measures

Measure	The EDN Group n=19 Participants Treating with (Endovascular Denervation) EDN at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation. endovascular denervation: Treating with endovascular denervation (EDN) at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation PTA: Treating with balloon dilation or stent implantation which were Percutaneous transluminal angioplasty (PTA)	The Control Group n=19 Participants Treating with balloon dilation or stent implantation only, PTA: Treating with balloon dilation or stent implantation which were Percutaneous transluminal angioplasty (PTA)
Rutherford Category	19 Participants	17 Participants

SECONDARY outcome

Timeframe: At 3 months post procedure

Number of Subjects with a decrease in Rutherford Category in 3 months (Rutherford category includes a total of 0-6 grades, grade 0 was asymptomatic, grade 1 was mild intermittent claudication, grade 2 was moderate intermittent claudication, grade 3 was severe intermittent claudication, grade 4 was resting pain, grade 5 was minor tissue defect, grade 6 was tissue ulcer, gangrene. The lower the grade, the better the results)

Outcome measures

Measure	The EDN Group n=19 Participants Treating with (Endovascular Denervation) EDN at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation. endovascular denervation: Treating with endovascular denervation (EDN) at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation PTA: Treating with balloon dilation or stent implantation which were Percutaneous transluminal angioplasty (PTA)	The Control Group n=19 Participants Treating with balloon dilation or stent implantation only, PTA: Treating with balloon dilation or stent implantation which were Percutaneous transluminal angioplasty (PTA)
Rutherford Category	19 Participants	13 Participants

SECONDARY outcome

Timeframe: At 1 week post procedure

Number of Subjects with a decrease in Rutherford Category in 1 week (Rutherford category includes a total of 0-6 grades, grade 0 was asymptomatic, grade 1 was mild intermittent claudication, grade 2 was moderate intermittent claudication, grade 3 was severe intermittent claudication, grade 4 was resting pain, grade 5 was minor tissue defect, grade 6 was tissue ulcer, gangrene. The lower the grade, the better the results)

Outcome measures

Measure	The EDN Group n=19 Participants Treating with (Endovascular Denervation) EDN at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation. endovascular denervation: Treating with endovascular denervation (EDN) at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation PTA: Treating with balloon dilation or stent implantation which were Percutaneous transluminal angioplasty (PTA)	The Control Group n=19 Participants Treating with balloon dilation or stent implantation only, PTA: Treating with balloon dilation or stent implantation which were Percutaneous transluminal angioplasty (PTA)
Rutherford Category	11 Participants	8 Participants

SECONDARY outcome

Timeframe: At 6 months post procedure

Median of numeric rating scale (NRS) scores in 6 months (NRS scores includes a total of 0-10 grades, No pain (0), Mild pain (1 ~ 3), Moderate pain (4 ~ 6), Severe pain (7 ~ 10), the lower the grade, the better the results)

Outcome measures

Measure	The EDN Group n=19 Participants Treating with (Endovascular Denervation) EDN at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation. endovascular denervation: Treating with endovascular denervation (EDN) at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation PTA: Treating with balloon dilation or stent implantation which were Percutaneous transluminal angioplasty (PTA)	The Control Group n=19 Participants Treating with balloon dilation or stent implantation only, PTA: Treating with balloon dilation or stent implantation which were Percutaneous transluminal angioplasty (PTA)
NRS Score	0 score on a scale Interval 0.0 to 0.0	0 score on a scale Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: At 3 months post procedure

Median of numeric rating scale (NRS) scores in 3 months (NRS scores includes a total of 0-10 grades, No pain (0), Mild pain (1 ~ 3), Moderate pain (4 ~ 6), Severe pain (7 ~ 10), the lower the grade, the better the results)

Outcome measures

Measure	The EDN Group n=19 Participants Treating with (Endovascular Denervation) EDN at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation. endovascular denervation: Treating with endovascular denervation (EDN) at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation PTA: Treating with balloon dilation or stent implantation which were Percutaneous transluminal angioplasty (PTA)	The Control Group n=19 Participants Treating with balloon dilation or stent implantation only, PTA: Treating with balloon dilation or stent implantation which were Percutaneous transluminal angioplasty (PTA)
NRS Score	0 score on a scale Interval 0.0 to 0.0	0 score on a scale Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: At 1 week post procedure

Median of numeric rating scale (NRS) scores in 1 week (NRS scores includes a total of 0-10 grades, No pain (0), Mild pain (1 ~ 3), Moderate pain (4 ~ 6), Severe pain (7 ~ 10), the lower the grade, the better the results)

Outcome measures

Measure	The EDN Group n=19 Participants Treating with (Endovascular Denervation) EDN at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation. endovascular denervation: Treating with endovascular denervation (EDN) at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation PTA: Treating with balloon dilation or stent implantation which were Percutaneous transluminal angioplasty (PTA)	The Control Group n=19 Participants Treating with balloon dilation or stent implantation only, PTA: Treating with balloon dilation or stent implantation which were Percutaneous transluminal angioplasty (PTA)
NRS Score	0 score on a scale Interval 0.0 to 2.0	1 score on a scale Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: From baseline to 6 months

MACE (Major adverse cardiovascular events, defined as cerebrovascular accident, myocardial infarction, or death.) and MALE (Major adverse limb events, defined as untreated loss of patency of the revascularization, reintervention on the revascularized segment, or major amputation of the revascularized limb) occurred cases from baseline to 6 months.

Outcome measures

Measure	The EDN Group n=19 Participants Treating with (Endovascular Denervation) EDN at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation. endovascular denervation: Treating with endovascular denervation (EDN) at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation PTA: Treating with balloon dilation or stent implantation which were Percutaneous transluminal angioplasty (PTA)	The Control Group n=19 Participants Treating with balloon dilation or stent implantation only, PTA: Treating with balloon dilation or stent implantation which were Percutaneous transluminal angioplasty (PTA)
Number of Participants With MACE (Major Adverse Cardiovascular Events) and MALE (Major Adverse Limb Events)	0 participants	0 participants

Adverse Events

The Control Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

The EDN Group

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	The Control Group n=19 participants at risk Treating with balloon dilation or stent implantation only, PTA: Treating with balloon dilation or stent implantation which were Percutaneous transluminal angioplasty (PTA)	The EDN Group n=19 participants at risk Treating with (Endovascular Denervation) EDN at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation. endovascular denervation: Treating with endovascular denervation (EDN) at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation PTA: Treating with balloon dilation or stent implantation which were Percutaneous transluminal angioplasty (PTA)
Injury, poisoning and procedural complications hematoma at puncture site	5.3% 1/19 • Number of events 1 • From baseline to 6 months	0.00% 0/19 • From baseline to 6 months
Injury, poisoning and procedural complications local arterial vasospasm	0.00% 0/19 • From baseline to 6 months	10.5% 2/19 • Number of events 2 • From baseline to 6 months

Additional Information

Dr. Gaojun Teng

Zhongda Hospital Affiliated to Southeast University

Phone: 13805175100

Email: gjteng@vip.sina.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place