Peripheral Arterial DiseaseSTRIKENCT06636968
A Real-world Study to Evaluate the Effectiveness of Intravascular Lithotripsy in Moderate to Severe Calcification Lesion of Lower Extremity Femoropopliteal Artery
An observational study of Peripheral Arterial Disease, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Vascular calcification is prevalent in patients with Peripheral artery disease (PAD), especially those with combined diabetes or chronic kidney disease. Severe calcification predicts poor prognosis and is independently associated with increased risk of cardiovascular death and morbidity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2024to 30 Jun 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: (1) Age more than 18 years old; (2) Smoking, diabetes, hypertension, hyperlipidemia and other high risk factors; (3) Clinical manifestations of lower extremity arteriosclerosis obliterans; (4) The distal artery pulsation of the ischemic limb is weakened or disappeared (5)ABI≤0.9; (6) Color Doppler ultrasound, CT angiography (CTA), magnetic resonance angiography (MR angiography) and Digital subtraction angiography (Digital subtraction angiography) angiography, Imaging tests such as DSA showed the stenosis or occlusion of the corresponding arteries. (6)Moderate-severe calcification of lower extremity arteries (defined as calcification on both sides of the arteries, the length of the lesion greater than 5cm).
Who may be able to join
- Patients older than 18 years
- Rutherford scale: Grades 2-5.
- Moderate-severe calcification of lower extremity arteries (defined as calcification on both sides of the arteries, the length of the lesion greater than 5cm).
- The stenosis degree of the lesions was more than 70% confirmed by DSA, including chronic occlusive lesions.
- At least one sub-knee branch artery is patent (defined as a run-off score of 1 or less). • In-stent restenosis or restenosis with moderate to severe calcification.
- The stenosis degree of inflow blood vessel on the diseased side is less than 30% or the residual stenosis is less than 30% after first-stage treatment.
- Calcification lesions with thrombus can also be included in the group after the thrombus is completely cleared.
- Sign relevant informed consent.
Who cannot join
- Active infection of the affected limb.
- Patients with severe ischemia of the affected limb who are expected to undergo major amputation.
- The target blood vessels were artificial blood vessels or autologous vessels.
- Simple thrombosis lesion.
- Thromboangiitis obliterans, arteritis or connective tissue disease-based lesions.
- Inflow vessel stenosis is greater than 30% or residual stenosis is still greater than 30% after primary treatment.
Show all 12Show fewer
- Allergic to contrast agent, heparin, anti-platelet therapy.
- Patients who are pregnant or lactating.
- Patients with cardiovascular and cerebrovascular events such as stroke or myocardial infarction within 3 months prior to enrollment.
- Patients who are currently in an ongoing interventional clinical study program.
- Patients who refuse to sign informed consent. •
- Patients who refuse to cooperate with long-term follow-up after surgery or who, for personal reasons, have difficulty communicating for quality of life assessment.
Trial locations and contacts
1 site in 1 country.
About this study
Vascular calcification is prevalent in patients with Peripheral artery disease (PAD), especially those with combined diabetes or chronic kidney disease. Severe calcification predicts poor prognosis and is independently associated with increased risk of cardiovascular death and morbidity. Calcification may also affect the outcome of endovascular therapy, leading to unsatisfactory vasodilation, and increase the risk of vascular complications (including restenosis) and dissection, perforation, and distal embolization. At present, according to the degree of calcification and the scope of the lesion, it can be divided into light, medium and severe three grades. Neither high pressure balloon nor atherectomy can significantly improve severe calcification. The efficacy of these treatments has also not been tested in multicenter, real-world studies. Shockwave balloon has been widely used in the clinical treatment of severe calcification due to its characteristics of significantly destroying the calcification structure, reducing the damage of vascular intima, and thus reducing postoperative complications. The currently published Disrupt PAD III Trial (NCT02923193) in calcified lesions showed shock wave balloon versus balloon expansion alone in a randomized controlled trial (RCT). The residual stenosis rate was lower (66.4% vs. 51.9%; p = 0.02), the incidence of fluid limiting intersections was low (1.4% vs. 6.8%; p = 0.03), the rate of post-expansion and recovery support was also low (5.2% vs. 17.0%; p = 0.001); (4.6% vs. 18.3%; p < 0.001). The shock wave balloon has been approved by the China Food and Drug Administration for the intracavitary treatment of severe femoral popliteal artery calcification. Due to its short market-time, it is currently only used in large vascular surgery centers. On this basis, investigators propose whether can set up a real-world study of shock wave balloon in the treatment of moderate and severe calcification, in order to explore the real efficacy of shock wave balloon in the treatment of moderate and severe calcification.
- Conditions
- Peripheral Arterial Disease
- Keywords
- calcification lesion, intravascular lithotripsy, lower-extremity arterial disease
- Medical subject headings
- Peripheral Arterial Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success rate
Defined as a final residual stenosis of less than 30% without a significant dissection (grade ≥D)
Measured: 7 Days
Secondary outcomes (11)
Bailout stent
The rate of bailout stent implantation.
Measured: 7 Days
Composite MAEs and embolization
Composite end point of major amputation plus operation-associated arterial embolization.
Measured: 1 month
operation-associated arterial embolization
Perioperative operation-associated arterial embolization
Measured: 7 Days
Dissection severity
Dissection after major procedure
Measured: 1 Day
Dissection severity-last
Dissection after last procesure
Measured: 1 Day
Major amputation
Major amputation rate in different frame
Measured: 1 year
Primary patency
Primary patency in different frame
Measured: 1 year
Freedom from TLR
Freedom from TLR in different frame
Measured: 1 year
Rutherford category
Rutherford grading improvement score after surgery（Rutherford Classification,0-6, higher scores mean a worse outcome）
Measured: 1 year
quality of life score
Postoperative quality of life score(15-items quality of recovery scale after, 0-150, higher scores mean a better outcome)
Measured: 1 year
Indicators of health economics
Cumulative hospitalization costs associated with target lesions and costs associated with endovascular therapy.
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start31 Jul 2024
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- RenJi Hospital, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology, Huashan Hospital, Dongfang Hospital Affiliated to Tongji University, Xuanwu Hospital, Beijing, Qingdao Haici Hospital, Second Affiliated Hospital of Soochow University, First Affiliated Hospital of Fujian Medical University, Quanzhou First Hospital, The Second Affiliated Hospital of Hainan Medical University, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, First Hospital of China Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06636968
- Sponsor's protocol ID
- The STRIKE study
- Other IDs
- B2024-270
- Acronym
- STRIKE
- Status last verified
- Sep 2024
- First submitted
- 23 Sep 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alfonso F, Perez-Vizcayno MJ, Cardenas A, Garcia Del Blanco B, Seidelberger B, Iniguez A, Gomez-Recio M, Masotti M, Velazquez MT, Sanchis J, Garcia-Touchard A, Zueco J, Bethencourt A, Melgares R, Cequier A, Dominguez A, Mainar V, Lopez-Minguez JR, Moreu J, Marti V, Moreno R, Jimenez-Quevedo P, Gonzalo N, Fernandez C, Macaya C; RIBS V Study Investigators, under the auspices of the Working Group on Interventional Cardiology of the Spanish Society of Cardiology. A randomized comparison of drug-eluting balloon versus everolimus-eluting stent in patients with bare-metal stent-in-stent restenosis: the RIBS V Clinical Trial (Restenosis Intra-stent of Bare Metal Stents: paclitaxel-eluting balloon vs. everolimus-eluting stent). J Am Coll Cardiol. 2014 Apr 15;63(14):1378-86. doi: 10.1016/j.jacc.2013.12.006. Epub 2014 Jan 8.
PubMed 24412457Werk M, Albrecht T, Meyer DR, Ahmed MN, Behne A, Dietz U, Eschenbach G, Hartmann H, Lange C, Schnorr B, Stiepani H, Zoccai GB, Hanninen EL. Paclitaxel-coated balloons reduce restenosis after femoro-popliteal angioplasty: evidence from the randomized PACIFIER trial. Circ Cardiovasc Interv. 2012 Dec;5(6):831-40. doi: 10.1161/CIRCINTERVENTIONS.112.971630. Epub 2012 Nov 27.
PubMed 23192918Liistro F, Porto I, Angioli P, Grotti S, Ricci L, Ducci K, Falsini G, Ventoruzzo G, Turini F, Bellandi G, Bolognese L. Drug-eluting balloon in peripheral intervention for below the knee angioplasty evaluation (DEBATE-BTK): a randomized trial in diabetic patients with critical limb ischemia. Circulation. 2013 Aug 6;128(6):615-21. doi: 10.1161/CIRCULATIONAHA.113.001811.
PubMed 23797811Jia X, Zhang J, Zhuang B, Fu W, Wu D, Wang F, Zhao Y, Guo P, Bi W, Wang S, Guo W. Acotec Drug-Coated Balloon Catheter: Randomized, Multicenter, Controlled Clinical Study in Femoropopliteal Arteries: Evidence From the AcoArt I Trial. JACC Cardiovasc Interv. 2016 Sep 26;9(18):1941-9. doi: 10.1016/j.jcin.2016.06.055.
PubMed 27659572Tarricone A, Ali Z, Rajamanickam A, Gujja K, Kapur V, Purushothaman KR, Purushothaman M, Vasquez M, Zalewski A, Parides M, Overbey J, Wiley J, Krishnan P. Histopathological Evidence of Adventitial or Medial Injury Is a Strong Predictor of Restenosis During Directional Atherectomy for Peripheral Artery Disease. J Endovasc Ther. 2015 Oct;22(5):712-5. doi: 10.1177/1526602815597683. Epub 2015 Jul 24.
PubMed 26208657Iida O, Takahara M, Soga Y, Hirano K, Yamauchi Y, Zen K, Yokoi H, Uematsu M; ZEPHYR investigators. Incidence and its characteristics of repetition of reintervention after drug-eluting stent implantation for femoropopliteal lesion. J Vasc Surg. 2016 Dec;64(6):1691-1695.e1. doi: 10.1016/j.jvs.2016.05.074. Epub 2016 Aug 27.
PubMed 27575807Zeller T, Dake MD, Tepe G, Brechtel K, Noory E, Beschorner U, Kultgen PL, Rastan A. Treatment of femoropopliteal in-stent restenosis with paclitaxel-eluting stents. JACC Cardiovasc Interv. 2013 Mar;6(3):274-81. doi: 10.1016/j.jcin.2012.12.118.
PubMed 23517839Dominguez A 3rd, Bahadorani J, Reeves R, Mahmud E, Patel M. Endovascular therapy for critical limb ischemia. Expert Rev Cardiovasc Ther. 2015 Apr;13(4):429-44. doi: 10.1586/14779072.2015.1019472. Epub 2015 Mar 2.
PubMed 25728744Xu Z, Ran X. Diabetic foot care in China: challenges and strategy. Lancet Diabetes Endocrinol. 2016 Apr;4(4):297-8. doi: 10.1016/S2213-8587(16)00051-6. No abstract available.
PubMed 27016321Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwalder U, Beregi JP, Claussen CD, Oldenburg A, Scheller B, Speck U. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. 2008 Feb 14;358(7):689-99. doi: 10.1056/NEJMoa0706356.
PubMed 18272892Tepe G, Brodmann M, Werner M, Bachinsky W, Holden A, Zeller T, Mangalmurti S, Nolte-Ernsting C, Bertolet B, Scheinert D, Gray WA; Disrupt PAD III Investigators. Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day Outcomes From the Randomized Disrupt PAD III Trial. JACC Cardiovasc Interv. 2021 Jun 28;14(12):1352-1361. doi: 10.1016/j.jcin.2021.04.010.
PubMed 34167675
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study to Evaluate the Effectiveness of Intravascular Lithotripsy in Moderate to Severe Calcification Lesion of Lower Extremity Femoropopliteal Artery
- ClinicalTrials.gov ID
- NCT06636968
- Acronym / sponsor ID
- STRIKE / The STRIKE study
- Conditions
- Peripheral Arterial Disease
- Keywords
- calcification lesion, intravascular lithotripsy, lower-extremity arterial disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- RenJi Hospital, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology, Huashan Hospital, Dongfang Hospital Affiliated to Tongji University, Xuanwu Hospital, Beijing, Qingdao Haici Hospital, Second Affiliated Hospital of Soochow University, First Affiliated Hospital of Fujian Medical University, Quanzhou First Hospital, The Second Affiliated Hospital of Hainan Medical University, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, First Hospital of China Medical University
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 15 Oct 2024 (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.
Vascular calcification is prevalent in patients with Peripheral artery disease (PAD), especially those with combined diabetes or chronic kidney disease. Severe calcification predicts poor prognosis and is independently associated with increased risk of cardiovascular death and morbidity. Calcification may also affect the outcome of endovascular therapy, leading to unsatisfactory vasodilation, and increase the risk of vascular complications (including restenosis) and dissection, perforation, and distal embolization. At present, according to the degree of calcification and the scope of the lesion, it can be divided into light, medium and severe three grades. Neither high pressure balloon nor atherectomy can significantly improve severe calcification. The efficacy of these treatments has also not been tested in multicenter, real-world studies. Shockwave balloon has been widely used in the clinical treatment of severe calcification due to its characteristics of significantly destroying the calcification structure, reducing the damage of vascular intima, and thus reducing postoperative complications. The currently published Disrupt PAD III Trial (NCT02923193) in calcified lesions showed shock wave balloon versus balloon expansion alone in a randomized controlled trial (RCT). The residual stenosis rate was lower (66.4% vs. 51.9%; p = 0.02), the incidence of fluid limiting intersections was low (1.4% vs. 6.8%; p = 0.03), the rate of post-expansion and recovery support was also low (5.2% vs. 17.0%; p = 0.001); (4.6% vs. 18.3%; p < 0.001). The shock wave balloon has been approved by the China Food and Drug Administration for the intracavitary treatment of severe femoral popliteal artery calcification. Due to its short market-time, it is currently only used in large vascular surgery centers. On this basis, investigators propose whether can set up a real-world study of shock wave balloon in the treatment of moderate and severe calcification, in order to explore the real efficacy of shock wave balloon in the treatment of moderate and severe calcification.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- (1) Age more than 18 years old; (2) Smoking, diabetes, hypertension, hyperlipidemia and other high risk factors; (3) Clinical manifestations of lower extremity arteriosclerosis obliterans; (4) The distal artery pulsation of the ischemic limb is weakened or disappeared (5)ABI≤0.9; (6) Color Doppler ultrasound, CT angiography (CTA), magnetic resonance angiography (MR angiography) and Digital subtraction angiography (Digital subtraction angiography) angiography, Imaging tests such as DSA showed the stenosis or occlusion of the corresponding arteries. (6)Moderate-severe calcification of lower extremity arteries (defined as calcification on both sides of the arteries, the length of the lesion greater than 5cm).
Key inclusion criteria (8 listed)
- Patients older than 18 years
- Rutherford scale: Grades 2-5.
- Moderate-severe calcification of lower extremity arteries (defined as calcification on both sides of the arteries, the length of the lesion greater than 5cm).
- The stenosis degree of the lesions was more than 70% confirmed by DSA, including chronic occlusive lesions.
- At least one sub-knee branch artery is patent (defined as a run-off score of 1 or less). • In-stent restenosis or restenosis with moderate to severe calcification.
Key exclusion criteria (12 listed)
- Active infection of the affected limb.
- Patients with severe ischemia of the affected limb who are expected to undergo major amputation.
- The target blood vessels were artificial blood vessels or autologous vessels.
- Simple thrombosis lesion.
- Thromboangiitis obliterans, arteritis or connective tissue disease-based lesions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Technical Success rate
Time frame: 7 Days
Defined as a final residual stenosis of less than 30% without a significant dissection (grade ≥D)
11 secondary outcomes
Bailout stent
Time frame: 7 Days
Composite MAEs and embolization
Time frame: 1 month
operation-associated arterial embolization
Time frame: 7 Days
Dissection severity
Time frame: 1 Day
Dissection severity-last
Time frame: 1 Day
Major amputation
Time frame: 1 year
Primary patency
Time frame: 1 year
Freedom from TLR
Time frame: 1 year
Rutherford category
Time frame: 1 year
quality of life score
Time frame: 1 year
Indicators of health economics
Time frame: 7 Days
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 15 Oct 2024.
- Background: PubMed 24412457Alfonso F, Perez-Vizcayno MJ, Cardenas A, Garcia Del Blanco B, Seidelberger B, Iniguez A, Gomez-Recio M, Masotti M, Velazquez MT, Sanchis J, Garcia-Touchard A, Zueco J, Bethencourt A, Melgares R, Cequier A, Dominguez A, Mainar V, Lopez-Minguez JR, Moreu J, Marti V, Moreno R, Jimenez-Quevedo P, Gonzalo N, Fernandez C, Macaya C; RIBS V Study Investigators, under the auspices of the Working Group on Interventional Cardiology of the Spanish Society of Cardiology. A randomized comparison of drug-eluting balloon versus everolimus-eluting stent in patients with bare-metal stent-in-stent restenosis: the RIBS V Clinical Trial (Restenosis Intra-stent of Bare Metal Stents: paclitaxel-eluting balloon vs. everolimus-eluting stent). J Am Coll Cardiol. 2014 Apr 15;63(14):1378-86. doi: 10.1016/j.jacc.2013.12.006. Epub 2014 Jan 8.
- Background: PubMed 23192918Werk M, Albrecht T, Meyer DR, Ahmed MN, Behne A, Dietz U, Eschenbach G, Hartmann H, Lange C, Schnorr B, Stiepani H, Zoccai GB, Hanninen EL. Paclitaxel-coated balloons reduce restenosis after femoro-popliteal angioplasty: evidence from the randomized PACIFIER trial. Circ Cardiovasc Interv. 2012 Dec;5(6):831-40. doi: 10.1161/CIRCINTERVENTIONS.112.971630. Epub 2012 Nov 27.
- Background: PubMed 23797811Liistro F, Porto I, Angioli P, Grotti S, Ricci L, Ducci K, Falsini G, Ventoruzzo G, Turini F, Bellandi G, Bolognese L. Drug-eluting balloon in peripheral intervention for below the knee angioplasty evaluation (DEBATE-BTK): a randomized trial in diabetic patients with critical limb ischemia. Circulation. 2013 Aug 6;128(6):615-21. doi: 10.1161/CIRCULATIONAHA.113.001811.
- Background: PubMed 27659572Jia X, Zhang J, Zhuang B, Fu W, Wu D, Wang F, Zhao Y, Guo P, Bi W, Wang S, Guo W. Acotec Drug-Coated Balloon Catheter: Randomized, Multicenter, Controlled Clinical Study in Femoropopliteal Arteries: Evidence From the AcoArt I Trial. JACC Cardiovasc Interv. 2016 Sep 26;9(18):1941-9. doi: 10.1016/j.jcin.2016.06.055.
- Background: PubMed 26208657Tarricone A, Ali Z, Rajamanickam A, Gujja K, Kapur V, Purushothaman KR, Purushothaman M, Vasquez M, Zalewski A, Parides M, Overbey J, Wiley J, Krishnan P. Histopathological Evidence of Adventitial or Medial Injury Is a Strong Predictor of Restenosis During Directional Atherectomy for Peripheral Artery Disease. J Endovasc Ther. 2015 Oct;22(5):712-5. doi: 10.1177/1526602815597683. Epub 2015 Jul 24.
- Background: PubMed 27575807Iida O, Takahara M, Soga Y, Hirano K, Yamauchi Y, Zen K, Yokoi H, Uematsu M; ZEPHYR investigators. Incidence and its characteristics of repetition of reintervention after drug-eluting stent implantation for femoropopliteal lesion. J Vasc Surg. 2016 Dec;64(6):1691-1695.e1. doi: 10.1016/j.jvs.2016.05.074. Epub 2016 Aug 27.
- Background: PubMed 23517839Zeller T, Dake MD, Tepe G, Brechtel K, Noory E, Beschorner U, Kultgen PL, Rastan A. Treatment of femoropopliteal in-stent restenosis with paclitaxel-eluting stents. JACC Cardiovasc Interv. 2013 Mar;6(3):274-81. doi: 10.1016/j.jcin.2012.12.118.
- Background: PubMed 25728744Dominguez A 3rd, Bahadorani J, Reeves R, Mahmud E, Patel M. Endovascular therapy for critical limb ischemia. Expert Rev Cardiovasc Ther. 2015 Apr;13(4):429-44. doi: 10.1586/14779072.2015.1019472. Epub 2015 Mar 2.
- Background: PubMed 27016321Xu Z, Ran X. Diabetic foot care in China: challenges and strategy. Lancet Diabetes Endocrinol. 2016 Apr;4(4):297-8. doi: 10.1016/S2213-8587(16)00051-6. No abstract available.
- Background: PubMed 18272892Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwalder U, Beregi JP, Claussen CD, Oldenburg A, Scheller B, Speck U. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. 2008 Feb 14;358(7):689-99. doi: 10.1056/NEJMoa0706356.
- Results publication: PubMed 34167675Tepe G, Brodmann M, Werner M, Bachinsky W, Holden A, Zeller T, Mangalmurti S, Nolte-Ernsting C, Bertolet B, Scheinert D, Gray WA; Disrupt PAD III Investigators. Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day Outcomes From the Randomized Disrupt PAD III Trial. JACC Cardiovasc Interv. 2021 Jun 28;14(12):1352-1361. doi: 10.1016/j.jcin.2021.04.010.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Shanghai Zhongshan Hospital 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 8 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2024. 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?
Technical Success rate (time frame: 7 Days). 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 NCT06636968, which also lists 11 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 15 Oct 2024.