Peripheral Arterial DiseaseCHOCO-PADNCT06933992

Safety and Efficacy of Chocolate Balloon Catheter in Peripheral Arterial Disease (CHOCO-PAD)

An observational study of Peripheral Arterial Disease, run by First People's Hospital of Hangzhou at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Peripheral Arterial Disease
What is being tested?: Chocolate PTA Balloon Catheter
Type of treatment: Medical device
How many people: 171 participants
Where: 1 siteChina
Study dates: 20 Jul 2025to 20 Dec 2027
Phase: Observational
Are there results?: Not yet: the study is under way

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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Participants will be selected from patients diagnosed with symptomatic peripheral artery disease (Rutherford class 2-5) who are undergoing percutaneous transluminal angioplasty (PTA) with the Chocolate balloon catheter as part of standard care. The ages of participants range from 18 to 80 years.

Who may be able to join

Participant or legal guardian provides written informed consent.
Age ≥18 and ≤80 years, regardless of gender.
De novo target lesion located in the native superficial femoral, popliteal, or infrapopliteal artery.
Life expectancy >1 year as assessed by the investigator.
Candidate suitable for endovascular angiography and intervention per investigator judgment.
Willingness to undergo Chocolate Balloon Catheter PTA.

Who cannot join

Active systemic infection or uncontrolled coagulation disorder within 14 days prior to procedure.
Planned major amputation of the target limb (at or above the ankle).
Renal insufficiency (MDRD eGFR ≤30 mL/min/1.73 m²) or serum creatinine ≥2.5 mg/dL within 30 days, or dialysis dependence.
Contraindication to antiplatelet therapy (aspirin/clopidogrel), low-molecular-weight heparin, vasodilators, or contrast agents.
Uncontrolled systemic comorbidities (e.g., severe cardiac/pulmonary/hepatic dysfunction, advanced malignancy, uncorrected coagulopathy).
History of cerebral hemorrhage, symptomatic stroke, myocardial infarction, or gastrointestinal bleeding within 6 months.

Show all 10Show fewer

Pregnancy, lactation, or planned pregnancy (men or women).
Participation in another interventional clinical trial with unmet primary endpoint.
Investigator-determined medical, social, or psychological contraindications.
Life expectancy <1 year.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

Hangzhou First People's Hospital
Hangzhou

Other trials in China

About this study

Official title: Evaluation of the Safety and Efficacy of the Chocolate Balloon Catheter in Percutaneous Transluminal Angioplasty (PTA) for Peripheral Arterial Disease (PAD): A Prospective, Multicenter, Single-Arm Observational Trial

This study aims to learn about the long-term safety and effectiveness of the Chocolate Balloon Catheter in patients with blocked leg arteries (peripheral artery disease, or PAD). The Chocolate Balloon is a special type of balloon used during minimally invasive procedures to open narrowed arteries while potentially causing less damage to the blood vessel.

The main question it aims to answer is:

Does the Chocolate Balloon keep the treated artery open after 12 months without needing repeat procedures? Patients with PAD who are already scheduled to undergo an artery-opening procedure (angioplasty) with the Chocolate Balloon as part of their standard care will answer the question about the safety and effectiveness of the Chocolate Balloon Catheter

Conditions: Peripheral Arterial Disease
Being tested: Chocolate PTA Balloon Catheter
Keywords: Chocolate Balloon Catheter, Percutaneous Transluminal Angioplasty, Peripheral Arterial Disease
Medical subject headings: Peripheral Arterial Disease

What participants receive

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

Chocolate PTA Balloon CatheterDevice
The Chocolate PTA balloon catheter is a nitinol-constrained percutaneous transluminal angioplasty balloon designed to minimize vessel trauma during treatment of peripheral arterial lesions. The device is used according to its standard indications and instructions for use in patients with symptomatic peripheral artery disease.

Study groups in NCT06933992
Study group	Role	What they receive
Chocolate PTA for PAD		This cohort comprises patients with symptomatic peripheral artery disease (Rutherford class 2-5) undergoing percutaneous transluminal angioplasty (PTA) using the Chocolate balloon catheter as part of routine care. Participants will be prospectively followed for 12 months to assess target lesion patency, revascularization rates, and clinical outcomes. Inclusion criteria: age ≥18 years, de novo/restenotic lesions (≤150 mm) in native lower limb arteries, and reference vessel diameter 4-6 mm. Receives: Device: Chocolate PTA Balloon Catheter

What is being measured

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

Target lesion patency rate at 12 months post-procedure
It is defined as the absence of restenosis (based on duplex Doppler ultrasound criteria: diameter stenosis >50% and peak systolic velocity ratio <2.5) and freedom from target lesion revascularization (TLR).
Measured: From enrollment to the end of treatment at 12 months

Secondary outcomes (6)

Rate of Acute Angiographic Success Defined as Core Lab-Assessed Residual Stenosis ≤30% Without Flow-Limiting Dissection (Grade D or Higher)
Proportion of participants achieving successful revascularization, defined by two co-primary angiographic criteria: 1) Core laboratory-adjudicated residual stenosis ≤30%, and 2) Absence of flow-limiting dissection (Grade D or higher per NHLBI classification), assessed immediately after device deployment.
Measured: From enrollment to the end of treatment at 12 months
Rate of bailout stenting
The proportion of cases requiring emergency stent placement due to suboptimal Chocolate balloon angioplasty results (e.g., severe dissection, recoil, or residual stenosis).
Measured: From enrollment to the end of treatment at 12 months
Number of Participants with Improvement in Rutherford Clinical Category from Baseline
Proportion of participants achieving ≥1 category reduction in Rutherford Clinical Classification (Scale Range: 0 [asymptomatic] to 6 [major tissue loss]) at 12 months post-procedure, as assessed by blinded core lab
Measured: From enrollment to the end of treatment at 12 months
Freedom from clinically driven Target Lesion Revascularization (TLR) at 1, 6, and 12 months
The rate of freedom from repeat revascularization (surgical or endovascular) of the target lesion due to symptoms or worsening blood flow at 1, 6, and 12 months.
Measured: From enrollment to the end of treatment at 12 months
Change in Ankle-Brachial Index (ABI) from Baseline
Mean difference in ABI (normal range: 0.9-1.3) measurements between pre-procedure baseline and 12-month follow-up, assessed by standardized vascular laboratory protocols. Higher values indicate better perfusion.
Measured: From enrollment to the end of treatment at 12 months
Change in Toe-Brachial Index (TBI) from Baseline
Mean difference in TBI (normal >0.6) measurements between pre-procedure baseline and 12-month follow-up, assessed by standardized vascular laboratory protocols. Higher values indicate better perfusion.
Measured: From enrollment to the end of treatment at 12 months

Timeline

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

20 Jul 202520 Dec 2027

First posted18 Apr 2025
Study start20 Jul 2025 (estimated)
Primary completion20 Jul 2027 (estimated)
Study completion20 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (25)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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 171 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06933992
Sponsor's protocol ID: NV-001-HZFH
Acronym: CHOCO-PAD
Status last verified: Apr 2025
First submitted: 10 Apr 2025
Last updated: 18 Apr 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Due to privacy and confidentiality concerns, individual participant data (IPD) will not be shared. The data contains sensitive health information that is protected by regulations, and sharing it may compromise participant confidentiality.

Publications

Babaev A, Zavlunova S, Attubato MJ, Martinsen BJ, Mintz GS, Maehara A. Orbital Atherectomy Plaque Modification Assessment of the Femoropopliteal Artery Via Intravascular Ultrasound (TRUTH Study). Vasc Endovascular Surg. 2015 Oct;49(7):188-94. doi: 10.1177/1538574415607361. Epub 2015 Oct 20.
PubMed 26490645
Lee MS, Canan T, Rha SW, Mustapha J, Adams GL. Pooled analysis of the CONFIRM registries: impact of gender on procedure and angiographic outcomes in patients undergoing orbital atherectomy for peripheral artery disease. J Endovasc Ther. 2015 Feb;22(1):57-62. doi: 10.1177/1526602814564367.
PubMed 25775681
Mintz GS, Popma JJ, Pichard AD, Kent KM, Satler LF, Chuang YC, Ditrano CJ, Leon MB. Patterns of calcification in coronary artery disease. A statistical analysis of intravascular ultrasound and coronary angiography in 1155 lesions. Circulation. 1995 Apr 1;91(7):1959-65. doi: 10.1161/01.cir.91.7.1959.
PubMed 7895353
Kawaguchi R, Tsurugaya H, Hoshizaki H, Toyama T, Oshima S, Taniguchi K. Impact of lesion calcification on clinical and angiographic outcome after sirolimus-eluting stent implantation in real-world patients. Cardiovasc Revasc Med. 2008 Jan-Mar;9(1):2-8. doi: 10.1016/j.carrev.2007.07.004.
PubMed 18206630
Kashyap VS, Pavkov ML, Bishop PD, Nassoiy SP, Eagleton MJ, Clair DG, Ouriel K. Angiography underestimates peripheral atherosclerosis: lumenography revisited. J Endovasc Ther. 2008 Feb;15(1):117-25. doi: 10.1583/07-2249R.1.
PubMed 18254670
Allison MA, Criqui MH, Wright CM. Patterns and risk factors for systemic calcified atherosclerosis. Arterioscler Thromb Vasc Biol. 2004 Feb;24(2):331-6. doi: 10.1161/01.ATV.0000110786.02097.0c. Epub 2003 Dec 4.
PubMed 14656730
Rocha-Singh KJ, Zeller T, Jaff MR. Peripheral arterial calcification: prevalence, mechanism, detection, and clinical implications. Catheter Cardiovasc Interv. 2014 May 1;83(6):E212-20. doi: 10.1002/ccd.25387. Epub 2014 Feb 10.
PubMed 24402839
Fitzgerald PJ, Ports TA, Yock PG. Contribution of localized calcium deposits to dissection after angioplasty. An observational study using intravascular ultrasound. Circulation. 1992 Jul;86(1):64-70. doi: 10.1161/01.cir.86.1.64.
PubMed 1617791
Hoffmann R, Mintz GS, Popma JJ, Satler LF, Kent KM, Pichard AD, Leon MB. Treatment of calcified coronary lesions with Palmaz-Schatz stents. An intravascular ultrasound study. Eur Heart J. 1998 Aug;19(8):1224-31. doi: 10.1053/euhj.1998.1028.
PubMed 9740344
Laird JR, Katzen BT, Scheinert D, Lammer J, Carpenter J, Buchbinder M, Dave R, Ansel G, Lansky A, Cristea E, Collins TJ, Goldstein J, Jaff MR; RESILIENT Investigators. Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: twelve-month results from the RESILIENT randomized trial. Circ Cardiovasc Interv. 2010 Jun 1;3(3):267-76. doi: 10.1161/CIRCINTERVENTIONS.109.903468. Epub 2010 May 18.
PubMed 20484101
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
Schillinger M, Sabeti S, Loewe C, Dick P, Amighi J, Mlekusch W, Schlager O, Cejna M, Lammer J, Minar E. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006 May 4;354(18):1879-88. doi: 10.1056/NEJMoa051303.
PubMed 16672699
Yokoi Y. How should recent endovascular trials for femoropopliteal artery disease be interpreted? Cardiovasc Interv Ther. 2017 Apr;32(2):106-113. doi: 10.1007/s12928-017-0463-z. Epub 2017 Mar 1.
PubMed 28251562
Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group; Bell K, Caporusso J, Durand-Zaleski I, Komori K, Lammer J, Liapis C, Novo S, Razavi M, Robbs J, Schaper N, Shigematsu H, Sapoval M, White C, White J, Clement D, Creager M, Jaff M, Mohler E 3rd, Rutherford RB, Sheehan P, Sillesen H, Rosenfield K. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Eur J Vasc Endovasc Surg. 2007;33 Suppl 1:S1-75. doi: 10.1016/j.ejvs.2006.09.024. Epub 2006 Nov 29. No abstract available.
PubMed 17140820
Rooke TW, Hirsch AT, Misra S, Sidawy AN, Beckman JA, Findeiss LK, Golzarian J, Gornik HL, Halperin JL, Jaff MR, Moneta GL, Olin JW, Stanley JC, White CJ, White JV, Zierler RE; Society for Cardiovascular Angiography and Interventions; Society of Interventional Radiology; Society for Vascular Medicine; Society for Vascular Surgery. 2011 ACCF/AHA Focused Update of the Guideline for the Management of Patients With Peripheral Artery Disease (updating the 2005 guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2011 Nov 1;58(19):2020-45. doi: 10.1016/j.jacc.2011.08.023. Epub 2011 Oct 6. No abstract available.
PubMed 21963765

Interested in taking part?

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 sites and contacts

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All Peripheral Arterial Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Safety and Efficacy of the Chocolate Balloon Catheter in Percutaneous Transluminal Angioplasty (PTA) for Peripheral Arterial Disease (PAD): A Prospective, Multicenter, Single-Arm Observational Trial
ClinicalTrials.gov ID: NCT06933992
Acronym / sponsor ID: CHOCO-PAD / NV-001-HZFH
Conditions: Peripheral Arterial Disease
Keywords: Chocolate Balloon Catheter, Percutaneous Transluminal Angioplasty, Peripheral Arterial Disease
Study type: Observational
Recruitment status: Enrolling by invitation
Enrolment: 171 participants (estimated)
Lead sponsor: First People's Hospital of HangzhouUniversity, hospital or other
Study start: 20 Jul 2025 (estimated)
Primary completion: 20 Jul 2027 (estimated)
Study completion: 20 Dec 2027 (estimated)
First posted: 18 Apr 2025 (actual)
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 main question it aims to answer is:

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Chocolate PTA for PAD	–	Device: Chocolate PTA Balloon CatheterThis cohort comprises patients with symptomatic peripheral artery disease (Rutherford class 2-5) undergoing percutaneous transluminal angioplasty (PTA) using the Chocolate balloon catheter as part of routine care. Participants will be prospectively followed for 12 months to assess target lesion patency, revascularization rates, and clinical outcomes. Inclusion criteria: age ≥18 years, de novo/restenotic lesions (≤150 mm) in native lower limb arteries, and reference vessel diameter 4-6 mm.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Participants will be selected from patients diagnosed with symptomatic peripheral artery disease (Rutherford class 2-5) who are undergoing percutaneous transluminal angioplasty (PTA) with the Chocolate balloon catheter as part of standard care. The ages of participants range from 18 to 80 years.

Key inclusion criteria (6 listed)

Participant or legal guardian provides written informed consent.
Age ≥18 and ≤80 years, regardless of gender.
De novo target lesion located in the native superficial femoral, popliteal, or infrapopliteal artery.
Life expectancy >1 year as assessed by the investigator.
Candidate suitable for endovascular angiography and intervention per investigator judgment.

Key exclusion criteria (10 listed)

Active systemic infection or uncontrolled coagulation disorder within 14 days prior to procedure.
Planned major amputation of the target limb (at or above the ankle).
Renal insufficiency (MDRD eGFR ≤30 mL/min/1.73 m²) or serum creatinine ≥2.5 mg/dL within 30 days, or dialysis dependence.
Contraindication to antiplatelet therapy (aspirin/clopidogrel), low-molecular-weight heparin, vasodilators, or contrast agents.
Uncontrolled systemic comorbidities (e.g., severe cardiac/pulmonary/hepatic dysfunction, advanced malignancy, uncorrected coagulopathy).

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
Chocolate PTA Balloon CatheterThe Chocolate PTA balloon catheter is a nitinol-constrained percutaneous transluminal angioplasty balloon designed to minimize vessel trauma during treatment of peripheral arterial lesions. The device is used according to its standard indications and instructions for use in patients with symptomatic peripheral artery disease.	Device	Chocolate PTA for PAD

Primary outcome

Target lesion patency rate at 12 months post-procedure
Time frame: From enrollment to the end of treatment at 12 months
It is defined as the absence of restenosis (based on duplex Doppler ultrasound criteria: diameter stenosis >50% and peak systolic velocity ratio <2.5) and freedom from target lesion revascularization (TLR).

6 secondary outcomes

Rate of Acute Angiographic Success Defined as Core Lab-Assessed Residual Stenosis ≤30% Without Flow-Limiting Dissection (Grade D or Higher)
Time frame: From enrollment to the end of treatment at 12 months
Rate of bailout stenting
Time frame: From enrollment to the end of treatment at 12 months
Number of Participants with Improvement in Rutherford Clinical Category from Baseline
Time frame: From enrollment to the end of treatment at 12 months
Freedom from clinically driven Target Lesion Revascularization (TLR) at 1, 6, and 12 months
Time frame: From enrollment to the end of treatment at 12 months
Change in Ankle-Brachial Index (ABI) from Baseline
Time frame: From enrollment to the end of treatment at 12 months
Change in Toe-Brachial Index (TBI) from Baseline
Time frame: From enrollment to the end of treatment at 12 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
Results publication: PubMed 26490645Babaev A, Zavlunova S, Attubato MJ, Martinsen BJ, Mintz GS, Maehara A. Orbital Atherectomy Plaque Modification Assessment of the Femoropopliteal Artery Via Intravascular Ultrasound (TRUTH Study). Vasc Endovascular Surg. 2015 Oct;49(7):188-94. doi: 10.1177/1538574415607361. Epub 2015 Oct 20.
Results publication: PubMed 25775681Lee MS, Canan T, Rha SW, Mustapha J, Adams GL. Pooled analysis of the CONFIRM registries: impact of gender on procedure and angiographic outcomes in patients undergoing orbital atherectomy for peripheral artery disease. J Endovasc Ther. 2015 Feb;22(1):57-62. doi: 10.1177/1526602814564367.
Results publication: PubMed 7895353Mintz GS, Popma JJ, Pichard AD, Kent KM, Satler LF, Chuang YC, Ditrano CJ, Leon MB. Patterns of calcification in coronary artery disease. A statistical analysis of intravascular ultrasound and coronary angiography in 1155 lesions. Circulation. 1995 Apr 1;91(7):1959-65. doi: 10.1161/01.cir.91.7.1959.
Results publication: PubMed 18206630Kawaguchi R, Tsurugaya H, Hoshizaki H, Toyama T, Oshima S, Taniguchi K. Impact of lesion calcification on clinical and angiographic outcome after sirolimus-eluting stent implantation in real-world patients. Cardiovasc Revasc Med. 2008 Jan-Mar;9(1):2-8. doi: 10.1016/j.carrev.2007.07.004.
Results publication: PubMed 18254670Kashyap VS, Pavkov ML, Bishop PD, Nassoiy SP, Eagleton MJ, Clair DG, Ouriel K. Angiography underestimates peripheral atherosclerosis: lumenography revisited. J Endovasc Ther. 2008 Feb;15(1):117-25. doi: 10.1583/07-2249R.1.
Results publication: PubMed 14656730Allison MA, Criqui MH, Wright CM. Patterns and risk factors for systemic calcified atherosclerosis. Arterioscler Thromb Vasc Biol. 2004 Feb;24(2):331-6. doi: 10.1161/01.ATV.0000110786.02097.0c. Epub 2003 Dec 4.
Results publication: PubMed 24402839Rocha-Singh KJ, Zeller T, Jaff MR. Peripheral arterial calcification: prevalence, mechanism, detection, and clinical implications. Catheter Cardiovasc Interv. 2014 May 1;83(6):E212-20. doi: 10.1002/ccd.25387. Epub 2014 Feb 10.
Results publication: PubMed 1617791Fitzgerald PJ, Ports TA, Yock PG. Contribution of localized calcium deposits to dissection after angioplasty. An observational study using intravascular ultrasound. Circulation. 1992 Jul;86(1):64-70. doi: 10.1161/01.cir.86.1.64.
Results publication: PubMed 9740344Hoffmann R, Mintz GS, Popma JJ, Satler LF, Kent KM, Pichard AD, Leon MB. Treatment of calcified coronary lesions with Palmaz-Schatz stents. An intravascular ultrasound study. Eur Heart J. 1998 Aug;19(8):1224-31. doi: 10.1053/euhj.1998.1028.
Results publication: PubMed 20484101Laird JR, Katzen BT, Scheinert D, Lammer J, Carpenter J, Buchbinder M, Dave R, Ansel G, Lansky A, Cristea E, Collins TJ, Goldstein J, Jaff MR; RESILIENT Investigators. Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: twelve-month results from the RESILIENT randomized trial. Circ Cardiovasc Interv. 2010 Jun 1;3(3):267-76. doi: 10.1161/CIRCINTERVENTIONS.109.903468. Epub 2010 May 18.
Results publication: 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.
Results publication: PubMed 16672699Schillinger M, Sabeti S, Loewe C, Dick P, Amighi J, Mlekusch W, Schlager O, Cejna M, Lammer J, Minar E. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006 May 4;354(18):1879-88. doi: 10.1056/NEJMoa051303.
Description the protocol of the studyLink provided by the sponsor.
Individual participant dataSharing planned: No. Due to privacy and confidentiality concerns, individual participant data (IPD) will not be shared. The data contains sensitive health information that is protected by regulations, and sharing it may compromise participant confidentiality.

Related trials for Peripheral Arterial Disease

Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Enrolling by invitationEarly Phase 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.

Meng Xiaohu, MS principal investigator

First People's Hospital of Hangzhou

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

Questions about this trial

What is this clinical trial studying?

An observational study of Peripheral Arterial Disease, run by First People's Hospital of Hangzhou at 1 site in China.

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 6 inclusion and 10 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: enrolling by invitation, as of the sponsor's last update on 18 Apr 2025. 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 China. 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?

This study is still under way. Results are not available in the source record yet.

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?

Target lesion patency rate at 12 months post-procedure (time frame: From enrollment to the end of treatment at 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 NCT06933992, which also lists 25 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 18 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.